Recall Z-1913-2019 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry XPT systems. The assay can be used to aid in the diagnosis and treatment of myoca
| Date | May 3, 2019 |
| Status | Terminated |
| Reason | A steady upward trend in blank (u) absorbance was observed |
| Root cause | Nonconforming Material/Component |
| Action | Siemens Healthineers issued Urgent Medical Device Recall notices to domestic customers and Urgent Field Safety Notices to international customers dated May 8, 2019. Actions to be Taken by the Customer 1) Discontinue use of and discard the kit lots listed on the notice. 2) Review your inventory of these products to determine your laboratorys replacement needs and provide information to Siemens for reporting to the authorities. 3) Complete and return the Field Correction Effectiveness Check letter within 30 days. 4) Please review the letter with your Medical Director. 5) If you have received |
| Quantity | 3,386 |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator Siemens Healthcare Diagnostics, Inc., Sep 7, 2016 |