Elecsys HIV Duo
Received Jul 28, 2026 · Event occurred Jul 4, 2026
Report 1823260-2026-03036 · MDR key 50053578
Device
Generic name
Hiv Detection Test
Manufacturer
Roche DiagnosticsCatalog number
08836973190
Lot number
888322
Product problems
- False Positive Result
Patient
48 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
We received an allegation about discrepant results for 1 patient sample tested with Elecsys HIV Duo assay on a cobas e 801 analytical unit.The initial result was 19.7 COI (Reactive).The 1st Repeat result was 19.5 COI (Reactive and accompanied by a data alarm).The sample was repeated at a different laboratory using the Chemiluminescent Microparticle Immunoassay (CMIA) methodology and the 2nd Repeat result was 0.07 S/CO (Non-Reactive).
Additional Manufacturer Narrative
The Elecsys HIV Duo reagent expiration date was not provided.The cobas e 801 analytical unit serial number was (b)(6).The last calibration was performed on 27-May-2026, and it was acceptable.The QC was in the expected range before sample measurement.The alarm trace showed no abnormal alarms occurred on the day of the event.The investigation is ongoing.