Medical Device Recall: 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: 0719079
Roche Diagnostics Operations, Inc. · August 15, 2024
Reason for Recall
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 Description
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
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
6504 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3187-2024
Status: ongoing
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