Recall Z-1097-2022 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Randox Laboratories Ltd.
CK MB Calibrator, Catalogue Number CK2393
| Date | Mar 25, 2022 |
| Status | Terminated |
| Reason | Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples. |
| Root cause | Under Investigation by firm |
| Action | Firm notified customers via email on March 25, 2022. The distributors and customers were instructed to discard previous target sheet and perform calibration with the realigned target value provided with the letter. Also, to complete and return the response form 12187-QA to technical.service@randox.com. |
| Quantity | 1,392 |
| Distribution | Domestic distribution to WV and PR. International distribution to Bangladesh, Bosnia & Herzegovina, Botswana, China, Colombia, Costa Rica, Croatia, Egypt, Fiji, France, Georgia, Germany, Ghana, Greece, Grenada, Hong Kong, India, Iraq, Italy, Lithuania, Malaysia, Maldives, Malta, Mexico, Morocco, Moz |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.