KIT COBAS 58/68/8800 DPX 480T US
Received Feb 11, 2026 · Event occurred Jan 16, 2026
Report 2243471-2026-00464 · MDR key 24312535
Device
Generic name
Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatiti
Manufacturer
Roche Molecular Systems, Inc. - BranchburgCatalog number
09040714190
Lot number
M26462
Product problems
- False Negative Result
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBERS OF THE ANALYZERS WERE (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF DISCREPANT RESULTS WITH THE KIT COBAS 58/68/8800 DPX 480T US ASSAY FOR DONOR PATIENT SAMPLES TESTED ON 4 COBAS 8800 ANALYZERS. THE PRIMARY POOL OF 96 (PP96) WAS B19 NON-REACTIVE. THE MANUFACTURING POOL WAS B19 REACTIVE.
Additional Manufacturer Narrative
A FULL REVIEW OF THE CUSTOMER'S DATA WAS PERFORMED FOR ALL FOUR COBAS® 8800 INSTRUMENTS THAT WERE OPERATING WITH THE LATEST SOFTWARE. THIS EVALUATION REVEALED NO ANOMALIES OR IRREGULAR DATA PATTERNS. THE INVESTIGATION REVEALED NO EVIDENCE OF FALSE-NEGATIVE B19 RESULTS. ADDITIONALLY, NO PRODUCT QUALITY ISSUE WAS IDENTIFIED.