Recall Z-0153-2020— Roche Diagnostics Operations, Inc.
Class III · Terminated
Class III FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2019-09-11, terminated 2024-06-11. It names one FDA 510(k) clearance: K131544. Product: Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.. Reason: Due to low Quality Control recovery and invalid Calibration..
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2019-09-11
- Terminated
- 2024-06-11
- Firm location
- Indianapolis, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
Reason for recall
Due to low Quality Control recovery and invalid Calibration.
Data sourced from openFDA. This site is unofficial and independent of the FDA.