COBAS® HIV-1/HIV-2 (192T)
Received Sep 11, 2025 · Event occurred Aug 17, 2021
Report 2243471-2025-02844 · MDR key 23030563
Device
Generic name
Lab-based Hiv Nat Diagnostic And/or Supplemental Test
Manufacturer
Roche Molecular Systems, Inc. - BranchburgCatalog number
07862113190
Lot number
G24271
Product problems
- False Negative Result
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
- False Negative Result
- Incorrect, Inadequate or Imprecise Result or Readings
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS® 6800 SYSTEM USED WAS WITH THE SERIAL NUMBER (B)(6). THE CUSTOMER'S DATA SHOWED THAT 3 PANEL SAMPLES WERE EXPECTED TO BE POSITIVE, BUT THEY RESULTED IN "NOT DETECTED". DURING AN INTERNAL INVESTIGATION BY DEVELOPMENT, THE SAME SAMPLES WERE PURCHASED AND TESTED. DEVELOPMENT REPRODUCED THE CUSTOMER¿S OBSERVATION OF INCONSISTENT RESULTS WHEN THE SAMPLES WERE TESTED AT CONCENTRATIONS > CA. 1E6 CP/ML. WHEN THE SAMPLES WERE DILUTED, APPROPRIATE HIV-2 REACTIVE/POSITIVE RESULTS WERE GENERATED. SEQUENCING OF THE SAMPLES REVEALED THEY WERE AS EXPECTED IN THE PCR-RELEVANT REGIONS.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT QUESTIONABLE LOW RESULTS FOR HIV-2 PANEL SAMPLES WHEN TESTED FOR COBAS® HIV-1/HIV-2 QUALITATIVE NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS, DURING AN INTERNAL VALIDATION TESTING. THE SAMPLES USED WERE HIGH-TITERED CONTRIVED SAMPLES (CELL CULTURE SUPERNATANTS) IN UNKNOWN LIQUID MATRICES.