Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the...
FDA Recall #Z-3187-2024 — Class II — August 15, 2024
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.
Recalling Firm
Roche Diagnostics Operations, Inc. — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
6504 units
Distribution
US Nationwide distribution.
Code Information
UDI-DI: 04015630940806 Lot Number: 755471 Exp. Date: 06/30/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated