Recall Z-1097-2022
Randox Laboratories Ltd. · initiated March 25, 2022
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
CK MB Calibrator, Catalogue Number CK2393
Codes / lots: GTIN 05055273201451 Lot 4410CK
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1097-2022
- Initiated
- March 25, 2022
- Terminated
- December 26, 2023
- Product code
- CGS – Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- 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, Mozambique, Nepal, Nigeria, Pakistan, Philippines, Poland, Puerto Rico, Romania, Russia, Saudi…
- Recalling firm
- Randox Laboratories Ltd., Crumlin, North