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Terminated

CK MB Calibrator, Catalogue Number CK2393

FDA Recall Z-1097-2022 · Posted None

Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeCGS
Date Initiated2022-03-25
Date Terminated2023-12-26
Product Quantity1,392

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.

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 [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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