KIT COBAS 58/68/8800 DPX 480T US
Received Sep 19, 2025 · Event occurred Dec 13, 2024
Report 2243471-2025-03248 · MDR key 23099333
Device
Generic name
Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatiti
Manufacturer
Roche Molecular Systems, Inc. - BranchburgCatalog number
09040714190
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER QUESTIONED THE RESULT CALLING AND INTERPRETATION OF THE COBAS DPX ASSAY ON THE COBAS SYNERGY G9 SERVER RACK. THE CONCERN INVOLVED THE POTENTIAL FOR FALSE NON-REACTIVE PARVOVIRUS B19 RESULTS DUE TO SUBOPTIMAL POLYMERASE CHAIN REACTION (PCR) GROWTH CURVES IN HIGH TITER PARVOVIRUS B19 SAMPLES. A REVIEW OF DATA FOR MULTIPLE BATCHES AND INSTRUMENTS REVEALED NO EVIDENCE OF FALSE NON-REACTIVE RESULTS FOR HIGH TITER PARVOVIRUS B19 SAMPLES DUE TO SUBOPTIMAL PCR GROWTH CURVES.
Additional Manufacturer Narrative
THE ANALYSIS WAS PERFORMED ON COBAS DPX INSTRUMENTS WITH SERIAL NUMBERS 5146 AND 5124. THE INVESTIGATION DETERMINED THAT THE COBAS DPX ASSAY PERFORMED WITHIN SPECIFICATIONS, AND NO FALSE NON-REACTIVE RESULTS FOR HIGH TITER PARVOVIRUS B19 SAMPLES WERE IDENTIFIED IN THE REVIEWED DATASET. THE ANALYSIS CONFIRMED THAT SUBOPTIMAL PCR GROWTH CURVES DID NOT RESULT IN FALSE NON-REACTIVE RESULTS. THE INVESTIGATION CONCLUDED THAT THE ASSAY WAS FUNCTIONING AS INTENDED, AND NO FURTHER ACTION WAS REQUIRED.