Z-3187-2024 Class II Ongoing
FDA device recall Z-3187-2024 was initiated by Roche Diagnostics Operations, Inc. on August 15, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 6504 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2024
- Initiation Date
- August 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6504 units
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
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.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI-DI: 04015630940806 Lot Number: 755471 Exp. Date: 06/30/2024