FDA-Device2024-10-02Class II
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
Roche Diagnostics Operations, Inc.
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.
Sold states
US Nationwide distribution.
Affected count
6504 units
Manufactured in
9115 Hague Rd, Indianapolis, IN, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3187-2024Don't want to check this manually?
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