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

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.

Roche issued Urgent Medical Device Corrections,TP-02225 and TP-02227 via UPS ground (08/15/2024). Roche engaged Sedgwick a third party recall company. Letter states reason for recall, health risk and action to take: Creatine Kinase kits, lot number 755471 expired on 06/30/2024. Ensure any inventory you have of this lot has been discarded per your local guidelines. " Follow your laboratory s standard operating procedures to determine specific clinical implications for your patients and whether retrospective review of patient results is required. " Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " If you received Recall Response Form (TP-02226) with this UMDC, complete all sections and fax it to 1-800-898-6169 or email it to [email protected] by September 1, 2024. If you did not receive the Recall Response Form with this UMDC, disregard this action. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information in this UMDC.