Device product

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

Z-3187-2024

August 15, 2024

Class II

Product summary

Firm: Roche Diagnostics Operations, Inc.
Event: Event 95221
Status: Ongoing
Classification: Class II
Quantity: 6504 units
Official record key: device-enforcement:Z-3187-2024

Official wording

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 information: UDI-DI: 04015630940806 Lot Number: 755471 Exp. Date: 06/30/2024

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.