Recall Z-3187-2024 ยท JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Roche Diagnostics Operations, Inc.
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
| Date | Sep 20, 2024 (initiated Aug 15, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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 yo |
| Quantity | 6504 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160570 | Creatine Kinase Roche Diagnostics Operations (Rdo), May 25, 2016 |