Recall Z-0115-2019 ยท JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
| Date | Jul 24, 2018 |
| Status | Terminated |
| Reason | A potential bias was identified with certain kits compared to the internal standards. |
| Root cause | Nonconforming Material/Component |
| Action | On July 24, 2018 Siemens Healthineers issued Urgent Medical Device Recall notices to U.S. customers and Urgent Field Safety Notices to OUS customers. The following are Actions to be Taken by the Customer: Customers using ADVIA Centaur CKMB Calibrator Lots ending in 64: - Review the notice with your Medical Director. - Review your inventory of these products and immediately order replacement ADVIA Centaur CKMB Calibrator kit lots ending in 68 by completing the Field Correction Effectiveness Check Form attached to the letter. - You may continue use of ADVIA Centaur CKMB Calibrator kit lots u |
| Quantity | 379 sets |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962126 | ACS CKMB II IMMUNOASSAY Ciba Corning Diagnostics Corp., Jun 21, 1996 |