ELECSYS HIV DUO
Received May 19, 2026 · Event occurred Jan 15, 2026
Report 1823260-2026-01977 · MDR key 25221845
Device
Generic name
Hiv Detection Test
Manufacturer
Roche DiagnosticsCatalog number
08836973162
Lot number
88832200
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER CHECKED THE ANALYER, BUT COULD NOT FIND A CAUSE. HE CHECKED ALL SIPPER, SAMPLE, AND REAGENT PROBES, VERIFIED THE TUBING AND ADJUSTMENTS, AND VERIFIED ALL MECHANISMS WERE ADJUSTED AND WORKING PROPERLY. HE RAN AN INSTRUMENT CHECK AND VERIFIED THAT ALL RESULTS PASSED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE-POSITIVE ELECSYS HIV DUO RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. THE SAMPLE WAS TESTED THREE TIMES. THE FIRST RESULT WAS 1.01 COI (POSITIVE). THE SECOND RESULT WAS 0.993 COI (NEGATIVE). THE THIRD RESULT WAS 1.01 COI (POSITIVE). THE LABORATORY'S SOP REQUIRES THAT THE THIRD RESULT BE RELEASED. THE SAMPLE WAS REPORTED AS POSITIVE. THE SAMPLE WAS THEN TESTED VIA CONFIRMATORY GENIUS HIV TESTING, AND THE RESULT WAS NEGATIVE. THE REPORTED RESULT WAS THEN CORRECTED.