medical Class II Updated 2024-10-02

Roche Diagnostics Operations, Inc. recalls Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS I

Recalled Product

Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190

Hazard / Issue

Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 04015630940806 Lot Number: 755471 Exp. Date: 06/30/2024
View official government recall

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