| Catalog Number |
06P02-60 |
| Medical Device Problem Code |
False Positive Result (1227)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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| Date of Event |
12/24/2023
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Type of Reportable Event
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Malfunction
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Additional Manufacturer Narrative
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Section a1 - patient identifier: sids = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Event or Problem Description
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The customer observed false repeat reactive alinity s hbsag results for multiple cadaveric samples which were confirmed as negative with nat testing.The following data was provided (<1.00 s/co is nonreactive, = 1.00 s/co is reactive): (b)(6).2024 sid (b)(6).Initial result = 1.98 s/co, repeats = 2.12 s/co and 1.97 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.13 s/co, repeats = 1.12 s/co and 1.18 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.34 s/co, repeats = 1.57 s/co and 1.46 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 6.32 s/co, repeats = 6.61 s/co and 6.82 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.16 s/co, repeats = 1.15 s/co and 1.14 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.71 s/co, repeats = 1.22 s/co and 1.17 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 3.74 s/co, repeats = 3.15 s/co and 3.22 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.34 s/co, repeats = 1.09 s/co and 1.29 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.51 s/co, repeats = 1.14 s/co and 1.18 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.22 s/co, repeats = 1.07 s/co and 1.12 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.54 s/co, repeats = 1.5 s/co and 1.28 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.8 s/co, repeats = 1.76 s/co and 1.64 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 2.43 s/co, repeats = 2.22 s/co and 2.21 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 10.65 s/co, repeats = 10.81 s/co and 11.26 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 101.55 s/co, repeats = 99.28 s/co and 85.11 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 1.46 s/co, repeats = 1.07 s/co and 5.45 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 2.72 s/co, repeats = 2.44 s/co and 2.69 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 4.99 s/co, repeats = 4.08 s/co and 3.87 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 1.69 s/co, repeats = 1.56 s/co and 1.62 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 4.12 s/co, repeats = 4.1 s/co and 4.44 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.25 s/co, repeats = 2.21 s/co and 2.9 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 4.6 s/co, repeats = 4.11 s/co and 4.18 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 5.47 s/co, repeats = 6.16 s/co and 5.55 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.32 s/co, repeats = 1.33 s/co and 1.51 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 4.23 s/co, repeats = 4.99 s/co and 4.44 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 1.47 s/co, repeats = 1.41 s/co and 1.51 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 2.32 s/co, repeats = 2.16 s/co and 2.03 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 2.47 s/co, repeats = 2.11 s/co and 2.18 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 1.56 s/co, repeats = 1.61 s/co and 1.60 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 1.07 s/co, repeats = 1.26 s/co and 1.16 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 2.56 s/co, repeats = 2.18 s/co and 1.75 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.51 s/co, repeats = 1.89 s/co and 2.07 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.58 s/co, repeats = 1.51 s/co and 1.45 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 1.32 s/co, repeats = 1.51 s/co and 1.33 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 2.39 s/co, repeats = 2.19 s/co and 2.13 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 1.62 s/co, repeats = 1.86 s/co and 2.03 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.55 s/co, repeats = 1.34 s/co and 1.41 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 1.89 s/co, repeats = 1.92 s/co and 1.96 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 2.75 s/co, repeats = 2.88 s/co and 2.50 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 4.76 s/co, repeats = 3.57 s/co and 3.62 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.10 s/co, repeats = 1.08 s/co and 1.04 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.02 s/co, repeats = 1.50 s/co and 1.47 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.71 s/co, repeats = 1.32 s/co and 1.23 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.55 s/co, repeats = 1.35 s/co and 1.36 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 3.08 s/co, repeats = 2.11 s/co and 1.83 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.41 s/co, repeats = 1.81 s/co and 1.94 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 7.22 s/co, repeats = 8.35 s/co and 7.60 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.31 s/co, repeats = 1.63 s/co and 1.62 s/co, nat = not ordered (b)(6).2023 sid (b)(6).Initial result = 1.83 s/co, repeats = 1.50 s/co and 1.55 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 4.96 s/co, repeats = 3.22 s/co and 4.84 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 2.61 s/co, repeats = 3.09 s/co and 3.40 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 11.97 s/co, repeats = 10.11 s/co and 9.87 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 16.55 s/co, repeats = 15.12 s/co and 16.01 s/co, nat = negative (b)(6).2023 sid (b)(6).Initial result = 4.28 s/co, repeats = 3.70 s/co and 4.00 s/co, nat = not ordered (b)(6).2024 sid (b)(6).Initial result = 2.02 s/co, repeats = 2.39 s/co and 2.43 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.02 s/co, repeats = 1.21 s/co and 1.19 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 7.36 s/co, repeats = 6.61 s/co and 6.62 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 3.63 s/co, repeats = 4.03 s/co and 4.49 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.45 s/co, repeats = 1.64 s/co and 1.82 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 3.36 s/co, repeats = 4.17 s/co and 3.4 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 2.80 s/co, repeats = 2.83 s/co and 2.71 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 8.62 s/co, repeats = 9.76 s/co and 9.69 s/co, nat = cancelled (b)(6).2024 sid (b)(6).Initial result = 2.30 s/co, repeats = 2.09 s/co and 2.14 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 6.44 s/co, repeats = 5.15 s/co and 5.12 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 4.09 s/co, repeats = 3.11 s/co and 3.07 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 24.24 s/co, repeats = 19.42 s/co and 18.01 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 3553.93 s/co, repeats = 3475.54 s/co and 3461.66 s/co, nat = not ordered (b)(6).2024 sid (b)(6).Initial result = 6.96 s/co, repeats = 6.60 s/co and 6.58 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 4.06 s/co, repeats = 3.45 s/co and 3.75 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.92 s/co, repeats = 1.56 s/co and 1.85 s/co, nat = not ordered (b)(6).2024 sid (b)(6).Initial result = 7.02 s/co, repeats = 6.46 s/co and 6.96 s/co, nat = not ordered (b)(6).2024 sid (b)(6).Initial result = 20.6 s/co, repeats = 16.1 s/co and 15.98 s/co, nat = not ordered (b)(6).2024 sid (b)(6).Initial result = 4.25 s/co, repeats = 6.12 s/co and 4.94 s/co, nat = not ordered (b)(6).2024 sid (b)(6).Initial result = 1.86 s/co, repeats = 2.12 s/co and 1.40 s/co, nat = not ordered (b)(6).2024 sid (b)(6).Initial result = 2.07 s/co, repeats = 2.0 s/co and 1.90 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.23 s/co, repeats = 1.22 s/co and 1.20 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.08 s/co, repeats = 1.23 s/co and 1.20 s/co, nat = not ordered (b)(6).2024 sid (b)(6).Initial result = 2.64 s/co, repeats = 2.24 s/co and 2.34 s/co, nat = not ordered (b)(6).2024 sid (b)(6).Initial result = 1.44 s/co, repeats = 1.43 s/co and 1.41 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 1.13 s/co, repeats = 1.07 s/co and 1.08 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 4.66 s/co, repeats = 4.50 s/co and 4.46 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 3.51 s/co, repeats = 3.24 s/co and 3.36 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 2.15 s/co, repeats = 1.55 s/co and 1.63 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 2.74 s/co, repeats = 2.95 s/co and 2.97 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 5.66 s/co, repeats = 4.44 s/co and 4.71 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 3.47 s/co, repeats = 3.67 s/co and 3.52 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 6.05 s/co, repeats = 5.9 s/co and 5.83 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 5.48 s/co, repeats = 4.6 s/co and 4.83 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 4.59 s/co, repeats = 6.54 s/co and 6.18 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 4.18 s/co, repeats = 4.25 s/co and 3.96 s/co, nat = negative (b)(6).2024 sid (b)(6).Initial result = 3.65 s/co, repeats = 3.77 s/co and 3.68 s/co, nat = negative there was no impact to patient management/donor management reported.
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Additional Manufacturer Narrative
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The complaint investigation for false reactive alinity s hbsag results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, labeling review, and field data review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates that the reagent lot performs as expected for this product.A review of the complaint trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot number 53198fn00 and complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.A review of customer field data was performed for the complaint lot.To assess field performance, initial reactive rates (irr), repeat reactive rates (rrr) and specificity (assuming 0 prevalence) were calculated for lot number 53198fn00.The overall reactive rates of ln 6p02-60 lot 53198fn00 across eurofins dpt denver corporate (usa), applicable peer sites and across a whole blood and plasma screening monitoring group were collected and assessed.No applicable peer site data was available for this lot at the time of the analysis.Across the whole blood and plasma monitoring group the performance of lot 53198fn00 is within product requirements and comparable to other lots analyzed in the comparison.Irr: 0.029 %, rrr: 0.016 %, specificity: 99.984 %.At eurofins dpt denver corporate (usa), the specificity performance of lot 53198fn00 is within package insert representative data for cadaveric specimens.The lot however has exhibited relatively higher reactive rates and lower specificity at the site as compared to the two previous lots used.Irr: 6.171 %, rrr: 5.771 %, specificity: 94.229 %.Based on the investigation, no systemic issue or deficiency was identified.The alinity s hbsag reagent, lot numbers 53198fn00 is performing as expected.
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Event or Problem Description
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The customer observed false repeat reactive alinity s hbsag results for multiple cadaveric samples which were confirmed as negative with nat testing.The following data was provided (<1.00 s/co is nonreactive, = 1.00 s/co is reactive): (b)(6) 2024 sid (b)(6) initial result = 1.98 s/co, repeats = 2.12 s/co and 1.97 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.13 s/co, repeats = 1.12 s/co and 1.18 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.34 s/co, repeats = 1.57 s/co and 1.46 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 6.32 s/co, repeats = 6.61 s/co and 6.82 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.16 s/co, repeats = 1.15 s/co and 1.14 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.71 s/co, repeats = 1.22 s/co and 1.17 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 3.74 s/co, repeats = 3.15 s/co and 3.22 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.34 s/co, repeats = 1.09 s/co and 1.29 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.51 s/co, repeats = 1.14 s/co and 1.18 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.22 s/co, repeats = 1.07 s/co and 1.12 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.54 s/co, repeats = 1.5 s/co and 1.28 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.8 s/co, repeats = 1.76 s/co and 1.64 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 2.43 s/co, repeats = 2.22 s/co and 2.21 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 10.65 s/co, repeats = 10.81 s/co and 11.26 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 101.55 s/co, repeats = 99.28 s/co and 85.11 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 1.46 s/co, repeats = 1.07 s/co and 5.45 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 2.72 s/co, repeats = 2.44 s/co and 2.69 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 4.99 s/co, repeats = 4.08 s/co and 3.87 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 1.69 s/co, repeats = 1.56 s/co and 1.62 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 4.12 s/co, repeats = 4.1 s/co and 4.44 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.25 s/co, repeats = 2.21 s/co and 2.9 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 4.6 s/co, repeats = 4.11 s/co and 4.18 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 5.47 s/co, repeats = 6.16 s/co and 5.55 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.32 s/co, repeats = 1.33 s/co and 1.51 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 4.23 s/co, repeats = 4.99 s/co and 4.44 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 1.47 s/co, repeats = 1.41 s/co and 1.51 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 2.32 s/co, repeats = 2.16 s/co and 2.03 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 2.47 s/co, repeats = 2.11 s/co and 2.18 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 1.56 s/co, repeats = 1.61 s/co and 1.60 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 1.07 s/co, repeats = 1.26 s/co and 1.16 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 2.56 s/co, repeats = 2.18 s/co and 1.75 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.51 s/co, repeats = 1.89 s/co and 2.07 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.58 s/co, repeats = 1.51 s/co and 1.45 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 1.32 s/co, repeats = 1.51 s/co and 1.33 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 2.39 s/co, repeats = 2.19 s/co and 2.13 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 1.62 s/co, repeats = 1.86 s/co and 2.03 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.55 s/co, repeats = 1.34 s/co and 1.41 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 1.89 s/co, repeats = 1.92 s/co and 1.96 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 2.75 s/co, repeats = 2.88 s/co and 2.50 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 4.76 s/co, repeats = 3.57 s/co and 3.62 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.10 s/co, repeats = 1.08 s/co and 1.04 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.02 s/co, repeats = 1.50 s/co and 1.47 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.71 s/co, repeats = 1.32 s/co and 1.23 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.55 s/co, repeats = 1.35 s/co and 1.36 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 3.08 s/co, repeats = 2.11 s/co and 1.83 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.41 s/co, repeats = 1.81 s/co and 1.94 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 7.22 s/co, repeats = 8.35 s/co and 7.60 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.31 s/co, repeats = 1.63 s/co and 1.62 s/co, nat = not ordered (b)(6) 2023 sid (b)(6) initial result = 1.83 s/co, repeats = 1.50 s/co and 1.55 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 4.96 s/co, repeats = 3.22 s/co and 4.84 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 2.61 s/co, repeats = 3.09 s/co and 3.40 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 11.97 s/co, repeats = 10.11 s/co and 9.87 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 16.55 s/co, repeats = 15.12 s/co and 16.01 s/co, nat = negative (b)(6) 2023 sid (b)(6) initial result = 4.28 s/co, repeats = 3.70 s/co and 4.00 s/co, nat = not ordered (b)(6) 2024 sid (b)(6) initial result = 2.02 s/co, repeats = 2.39 s/co and 2.43 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.02 s/co, repeats = 1.21 s/co and 1.19 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 7.36 s/co, repeats = 6.61 s/co and 6.62 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 3.63 s/co, repeats = 4.03 s/co and 4.49 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.45 s/co, repeats = 1.64 s/co and 1.82 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 3.36 s/co, repeats = 4.17 s/co and 3.4 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 2.80 s/co, repeats = 2.83 s/co and 2.71 s/co, nat = negative (b)(6) 2024 sid s-010124-00694 initial result = 8.62 s/co, repeats = 9.76 s/co and 9.69 s/co, nat = cancelled (b)(6) 2024 sid (b)(6) initial result = 2.30 s/co, repeats = 2.09 s/co and 2.14 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 6.44 s/co, repeats = 5.15 s/co and 5.12 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 4.09 s/co, repeats = 3.11 s/co and 3.07 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 24.24 s/co, repeats = 19.42 s/co and 18.01 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 3553.93 s/co, repeats = 3475.54 s/co and 3461.66 s/co, nat = not ordered (b)(6) 2024 sid (b)(6) initial result = 6.96 s/co, repeats = 6.60 s/co and 6.58 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 4.06 s/co, repeats = 3.45 s/co and 3.75 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.92 s/co, repeats = 1.56 s/co and 1.85 s/co, nat = not ordered (b)(6) 2024 sid (b)(6) initial result = 7.02 s/co, repeats = 6.46 s/co and 6.96 s/co, nat = not ordered (b)(6) 2024 sid (b)(6) initial result = 20.6 s/co, repeats = 16.1 s/co and 15.98 s/co, nat = not ordered (b)(6) 2024 sid (b)(6) initial result = 4.25 s/co, repeats = 6.12 s/co and 4.94 s/co, nat = not ordered (b)(6) 2024 sid (b)(6) initial result = 1.86 s/co, repeats = 2.12 s/co and 1.40 s/co, nat = not ordered (b)(6) 2024 sid (b)(6) initial result = 2.07 s/co, repeats = 2.0 s/co and 1.90 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.23 s/co, repeats = 1.22 s/co and 1.20 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.08 s/co, repeats = 1.23 s/co and 1.20 s/co, nat = not ordered (b)(6) 2024 sid (b)(6) initial result = 2.64 s/co, repeats = 2.24 s/co and 2.34 s/co, nat = not ordered (b)(6) 2024 sid (b)(6) initial result = 1.44 s/co, repeats = 1.43 s/co and 1.41 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 1.13 s/co, repeats = 1.07 s/co and 1.08 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 4.66 s/co, repeats = 4.50 s/co and 4.46 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 3.51 s/co, repeats = 3.24 s/co and 3.36 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 2.15 s/co, repeats = 1.55 s/co and 1.63 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 2.74 s/co, repeats = 2.95 s/co and 2.97 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 5.66 s/co, repeats = 4.44 s/co and 4.71 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 3.47 s/co, repeats = 3.67 s/co and 3.52 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 6.05 s/co, repeats = 5.9 s/co and 5.83 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 5.48 s/co, repeats = 4.6 s/co and 4.83 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 4.59 s/co, repeats = 6.54 s/co and 6.18 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 4.18 s/co, repeats = 4.25 s/co and 3.96 s/co, nat = negative (b)(6) 2024 sid (b)(6) initial result = 3.65 s/co, repeats = 3.77 s/co and 3.68 s/co, nat = negative there was no impact to patient management/donor management reported.
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