KIT COBAS 58/68/8800 DPX 480T US
Received Sep 22, 2025 · Event occurred Dec 13, 2024
Report 2243471-2025-03364 · MDR key 23111301
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
Additional Manufacturer Narrative
THE REPORTED EVENT OCCURRED ON A COBAS SYNERGY G9 SERVER RACK WITH SERIAL NUMBER (B)(6). THE INVESTIGATION INCLUDED A REVIEW OF COBAS DPX ASSAY DATA FOR SERIAL NUMBER (B)(6), BATCH 3924, DATED 06-DEC-2024. THE ANALYSIS DETERMINED THAT NO FALSE NON-REACTIVE PARVOVIRUS B19 RESULTS OCCURRED DUE TO SUBOPTIMAL PCR GROWTH CURVES IN THE REVIEWED DATASET. THE DATASET WAS EVALUATED USING SPECIFIC ALGORITHMIC PARAMETERS, WHICH CONFIRMED THE ABSENCE OF HIGH-TITER FALSE NON-REACTIVE RESULTS. THE PROPRIETARY PARAMETERS WERE GRAPHICALLY REVIEWED TO ENSURE THE ACCURACY OF THE RESULTS. THE INVESTIGATION CONCLUDED THAT THE COBAS DPX ASSAY PERFORMED WITHIN SPECIFICATIONS, AND NO FURTHER ACTION WAS DEEMED NECESSARY BASED ON THE AVAILABLE INFORMATION.
Description of Event or Problem
THE INITIAL REPORTER QUESTIONED THE RESULT CALLING AND INTERPRETATION OF THE KIT COBAS 58/68/8800 DPX 480T US ASSAY ON THE COBAS SYNERGY G9 SERVER RACK.