FDA Enforcement
Class II
Ongoing
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
Recall: Z-3187-2024
·
Reported October 2, 2024
Enforcement
- Recall Number
- Z-3187-2024
- Event ID
- 95221
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Roche Diagnostics Operations, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 2, 2024
- Initiation Date
- August 15, 2024
- Classification Date
- September 20, 2024
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025, United States
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
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.
Code Info
UDI-DI: 04015630940806 Lot Number: 755471 Exp. Date: 06/30/2024
Distribution
US Nationwide distribution.
Quantity
6504 units