Device 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.
Z-0153-2020
Product summary
- Event
- Event 83806
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,304 units
- Official record key
device-enforcement:Z-0153-2020
Official wording
Reason: Due to low Quality Control recovery and invalid Calibration.
Code information: Lot # 36133801
Distribution pattern: US Nationwide distribution including the states of AL, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, NE, NH, NJ, NY, OH, OK, PA, PR, RI, SC, TN, TX, UT, VA and WI. Updated as of 12/20/19 to include the following additional US states: CO.
Derived failure modes
-
Unknown
Due to low Quality Control recovery and invalid Calibration.