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Recall Observatory FDA recall evidence

Device product

CK MB Calibrator, Catalogue Number CK2393

Z-1097-2022

March 25, 2022

Class III

Product summary

Firm
Randox Laboratories Ltd.
Event
Event 90046
Status
Terminated
Classification
Class III
Quantity
1,392
Official record key
device-enforcement:Z-1097-2022

Official wording

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.

Code information: GTIN 05055273201451 Lot 4410CK

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.