Roche Diagnostics Operations, Inc.: Device Recall
Recall #Z-3187-2024 · 08/15/2024
Class II: Risk
Recall Details
- Recall Number
- Z-3187-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Status
- Ongoing
- Date Initiated
- 08/15/2024
- Location
- Indianapolis, IN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6504 units
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 Pattern
US Nationwide distribution.
Other Recalls by Roche Diagnostics Operations, Inc.
- Class II: Risk 11/21/2025
- Class II: Risk 10/17/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.