KIT COBAS 58/68/8800 MPX 480T US
Received Jan 30, 2026 · Event occurred Nov 21, 2025
Report 2243471-2026-00324 · MDR key 24222760
Device
Generic name
Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatiti
Manufacturer
Roche Molecular Systems, Inc. - BranchburgCatalog number
09040854190
Lot number
M20085
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS 8800 SERIAL NUMBER WAS (B)(6). THE DATA ANALYSIS REVEALED NO ANOMALIES IN THE ALGORITHM THAT COULD LEAD TO ERRONEOUS OUTCOMES. BASED ON THESE RESULTS, THE POSSIBILITY OF CONTAMINATION CANNOT BE EXCLUDED. THE REACTIVE HCV RESULT IS LIKELY ATTRIBUTABLE TO A VERY LOW VIRAL LOAD, POSITIONED NEAR OR BELOW THE ASSAY'S LIMIT OF DETECTION (LOD). THIS IS EVIDENCED BY A WEAK PCR GROWTH CURVE AND AN HCV REACTIVE RESULT WITH A HIGH CT VALUES AROUND 40. AT CONCENTRATIONS NEAR THE LOD, SAMPLES OFTEN EXHIBIT STOCHASTIC (RANDOM) DETECTION; THEY MAY FLUCTUATE BETWEEN REACTIVE AND NON-REACTIVE OUTCOMES ACROSS MULTIPLE TESTS DUE TO A REDUCED REACTIVITY RATE. THIS VARIABILITY IS EXPECTED WITH LOW-TITER SAMPLES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Description of Event or Problem
THERE WAS AN ALLEGATION OF DISCREPANT HCV RESULTS WITH THE COBAS®MPX KIT (480T) FROM THE COBAS 8800 ANALYZER FOR A SINGLE PATIENT. THE INITIAL POOLED SAMPLE GENERATED A NON-REACTIVE RESULT FOR HIV, HBV, AND HCV. A RE-POOLED SAMPLE WAS REPEATED THE NEXT DAY AND GENERATED A NON-REACTIVE RESULT FOR HIV AND HBV AND A REACTIVE RESULT FOR HCV WITH CT 39.05. AN INDIVIDUAL DONOR TEST WAS PERFORMED AND A REACTIVE HCV RESULT WAS GENERATED WITH CT 40.4. SEROLOGY TESTING WAS PERFORMED AND GENERATED A NON-REACTIVE RESULT.