DETERMINE HIV-1/2 AG/AB COMBO 25T

Additional Manufacturer Narrative

B3 - THE DATE OF THE EVENT IS AN APPROXIMATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED.THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

Description of Event or Problem

THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON UNKNOWN DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH DETERMINE HIV 1/2 AG/AB COMBO TEST PERFORMED ON AN UNKNOWN DATE IN (B)(6) 2026. IT IS UNKNOWN IF ADDITIONAL TESTING WAS PERFORMED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING OUTCOME, WAS PROVIDED.