medical Class III Updated 2019-10-23

Roche Diagnostics Operations, Inc. recalls Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 -

Recalled 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.


Hazard / Issue

Due to low Quality Control recovery and invalid Calibration.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 36133801
View official government recall

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