FDAAugust 15, 2024device
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
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
roche diagnostics operationsrocheroche diagnostics
UPCs
0401563094080607190794190
Recall history
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