KIT COBAS 58/68/8800 DPX 480T US
Received Sep 19, 2025 · Event occurred Dec 23, 2024
Report 2243471-2025-03247 · MDR key 23099591
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 DETERMINED THAT THE COBAS DPX ASSAY PERFORMED WITHIN SPECIFICATIONS. A REVIEW OF THE COBAS DPX PARVOVIRUS B19 SAMPLE RESULTS CONFIRMED THAT NO HIGH-TITER FALSE NON-REACTIVE RESULTS OCCURRED DUE TO SUBOPTIMAL PCR GROWTH CURVES IN THE REVIEWED DATASET.
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.