MalfunctionQST
COBAS® HIV-1/HIV-2 QUALITATIVE (192T)
Received May 13, 2026 · Event occurred Apr 21, 2026
Report 2243471-2026-01882 · MDR key 25159407
Device
Generic name
Lab-based Hiv Nat Diagnostic And/or Supplemental Test
Manufacturer
Roche Molecular Systems, Inc. - BranchburgCatalog number
09040528190
Lot number
N03138
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE COBAS® HIV-1/HIV-2 QUALITATIVE (192T) ASSAY RESULTS FOR FOUR PATIENT SAMPLES TESTED ON THE COBAS 5800 ANALYZER. THE INITIAL RESULTS WERE POSITIVE FOR HIV-1. THE REPEAT RESULTS WERE NEGATIVE USING THE COBAS® HIV-1 QUANTITATIVE ASSAY ON THE COBAS 6800 ANALYZER.