Roche Diagnostics Operations, Inc. recalls Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determina

Recalled October 2, 2024 · FDA recall Z-3187-2024 · Roche Diagnostics Operations

Hazard

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. · FDA Class II

Units

6504 units

Sold at

US Nationwide distribution.

Description

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.

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

Manufacturer(s)

Roche Diagnostics Operations, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →