FDAFDA · Food and drugs·Recall number Z-3187-2024
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
Published October 2, 2024 · Recall initiated: August 15, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- UDI-DI: 04015630940806 Lot Number: 755471 Exp. Date: 06/30/2024
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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