CK MB Calibrator, Catalogue Number CK2393
This recall has been terminated (originally issued March 25, 2022).
- Recall Initiated
- March 25, 2022
- Terminated
- December 26, 2023
- Recall Number
- Z-1097-2022
- Quantity
- 1,392
- Official Source
- View on FDA website ↗
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.
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 Arabia, South Korea, Switzerland, Thailand, Turkey, UK, Uruguay, Uzbekistan and Vietnam.
Lot / Code Info
GTIN 05055273201451 Lot 4410CK
Root 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.