MAUDE Adverse Event Report: ABBOTT GMBH ALINITY S ANTI-HCV II REAGENT KIT; SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO

Catalog Number	04W56-60
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed false reactive alinity s anti-hcv ii results for numerous tissue and organ donors.The customer reported that for tissue donors from (b)(6) 2025, 24 donor samples were repeat reactive with the alinity s anti-hcv assay.Those 24 reactive samples were tested with nat and 19 samples were negative.Those 19 confirmed negative samples were then tested with an ortho anti-hcv assay and 13 were nonreactive and 6 were reactive.The customer was using ortho anti-hcv as their primary means of testing tissue donors from (b)(6) 2024 to (b)(6), 2025, and there were 13 donor samples that were repeat reactive.Those 13 samples were tested with nat and 8 were negative.The 8 confirmed negatives samples were tested with the alinity s anti-hcv assay and 3 were nonreactive and 5 were repeat reactive.The customer reported that for organ donors from (b)(6) 2025, 20 donor samples were repeat reactive with the alinity s anti-hcv assay.Those 20 reactive samples were tested with nat and 8 samples were negative.Those 8 confirmed negative samples were then tested with an ortho anti-hcv assay and 3 were nonreactive and 5 were reactive.The customer was using ortho anti-hcv as their primary means of testing organ donors from (b)(6) 2024 to (b)(6) 2025, and there were 28 donor samples that were repeat reactive.Those 28 reactive samples were tested with nat and 15 were negative.The 15 confirmed negatives samples were tested with the alinity s anti-hcv assay and 0 were nonreactive and 15 were repeat reactive.There was no further information provided by the customer.There was no impact to patient or donor management reported.
Event or Problem Description
The customer observed false reactive alinity s anti-hcv ii results for numerous tissue and organ donors.The customer reported that for tissue donors from (b)(6) 2025, 24 donor samples were repeat reactive with the alinity s anti-hcv assay.Those 24 reactive samples were tested with nat and 19 samples were negative.Those 19 confirmed negative samples were then tested with an ortho anti-hcv assay and 13 were nonreactive and 6 were reactive.The customer was using ortho anti-hcv as their primary means of testing tissue donors from august 2024 to january 26, 2025, and there were 13 donor samples that were repeat reactive.Those 13 samples were tested with nat and 8 were negative.The 8 confirmed negatives samples were tested with the alinity s anti-hcv assay and 3 were nonreactive and 5 were repeat reactive.The customer reported that for organ donors from february to(b)(6) 2025, 20 donor samples were repeat reactive with the alinity s anti-hcv assay.Those 20 reactive samples were tested with nat and 8 samples were negative.Those 8 confirmed negative samples were then tested with an ortho anti-hcv assay and 3 were nonreactive and 5 were reactive.The customer was using ortho anti-hcv as their primary means of testing organ donors from august 2024 to january 26, 2025, and there were 28 donor samples that were repeat reactive.Those 28 reactive samples were tested with nat and 15 were negative.The 15 confirmed negatives samples were tested with the alinity s anti-hcv assay and 0 were nonreactive and 15 were repeat reactive.There was no further information provided by the customer.There was no impact to patient or donor management reported.
Additional Manufacturer Narrative
The complaint investigation for false reactive alinity s anti-hcv ii results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.A review of tracking and trending for the product and the lot did not identify an increase in complaint activity.Device history record review did not identify any non-conformances or deviations with the likely cause lot numbers, 65252be00 and 67662be00, and complaint issue.A review of reactive rates and specificity (assuming zero prevalence) for alinity s anti-hcv ii, list number 4w56-60, and for lots 65252be00 and 67662be00, specifically, was performed utilizing field data.Cts-phx processes a small number of transplant specimens.For the purposes of this complaint evaluation, the samples known to be transplant specimens were identified (cts-phx-tr) and compared to the selected transplant peer group and the confidence interval of representative data from cadaveric specimens for the assay.Overall reactive rates and specificity (assuming 0 prevalence) of ln 4w56-60, and for lots 65252be00 and 67662be00 across cts-phx-tr, applicable transplant peer sites, and across a whole blood and plasma group were collected and assessed.Across the whole blood and plasma group the performance of lots 65252be00 and 67662be00 is within product requirements and comparable to other 4w56-60 lots analyzed in the comparison.Monthly performance comparison between cts-phx blood-screening data versus cts-phx-tr transplant data suggests that the variability in transplant specimen performance may be influenced by sample-specific or external factors rather than alinity s anti-hcv ii assay performance.The alinity s anti-hcv ii assay was designed with improved seroconversion sensitivity.Improved assay performance over assays from earlier, or even the same generation, can cause discrepant results between different serologic platforms and inconsistency on repeat testing.Cadaveric samples are noted to contain particulate matter and cellular debris from postmortem autolysis.Both are known interferents and not fully characterizable in a timely manner with current technologies and knowledge.Complete alignment of results for identical samples may not occur between methods when performing a method comparison.Differences between sample results using the past method and the new method may be due to a difference in sensitivity or specificity.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, alinity s anti-hcv ii, lot numbers 65252be00 and 67662be00, are performing as intended and no systemic issue or deficiency was identified.

• Brand Name: ALINITY S ANTI-HCV II REAGENT KIT
• Common Device Name: SEROLOGY TESTS USED FOR INFECTIOUS DISEASE SCREENING OF BLOOD AND PLASMA DONATIO
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22582816
• Report Number: 3002809144-2025-00245
• Device Sequence Number: 17265405
• Product Code: QHM
• UDI-Device Identifier: 00380740177706
• UDI-Public: (01)00380740177706(17)251009(10)67662BE00
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: BL125759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2025
• Device Catalogue Number: 04W56-60
• Device Lot Number: 67662BE00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY S ANTI HCV II RGT, 04W56-60, 65252BE00,; ALNTY S ANTI HCV II RGT, 04W56-60, 65252BE00.; ALNTY S SYSTEM, 06P16-01, (B)(6),; ALNTY S SYSTEM, 06P16-01, (B)(6),
• Patient Sex: Unknown