The customer observed false reactive alinity s hiv ag/ab results for one cadaveric tissue donor that was nat negative.The following data was provided: (b)(6) 2022, sid (b)(6), initial result = 4.75 s/co, repeats = 1.08 s/co and 0.94 s/co, hemolysis = 100 mg/dl to 250 mg/dl.The tissue donation was rejected and not collected or discarded.No additional impact to patient management was reported.
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The complaint investigation for false reactive alinity s hiv ag/ab 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.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances, potential non-conformances or deviations with lot 37456be00.Labeling was reviewed and sufficiently addresses the customer's issue.A technical review of field data for alinity s hiv ag/ab was performed.Across all us blood screening customers, the initial reactive rate (irr), repeat reactive rate (rrr) and specificity (assuming zero prevalence) observed for lot 37456be00 is within product requirements, within package insert representative data for cadaveric specimens and comparable to other lots analyzed in the comparison.At mats the performance of lot 37456be00 is within package insert representative data for cadaveric specimens and the ir-rr rates are lower as compared to peer sites.Based on the information within the complaint record, the device met performance specifications at the customer site as all reactive rates were within product requirements respectively package insert claims for cadaveric testing.Based on the investigation alinity s hiv ag/ab reagent lot 37456be00 is performing as intended, no systemic issue or deficiency of alinity s hiv ag/ab reagent was identified.
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