DETERMINE HIV-1/2 AG/AB COMBO 25T
Received Jun 29, 2026 · Event occurred Mar 1, 2026
Report 1221359-2026-00192 · MDR key 25659959
Device
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 ONE (1) 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.
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.