Randox Laboratories Ltd. recalls CK MB Calibrator, Catalogue Number CK2393

Recall date

March 25, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1097-2022

FDA classification

Class III

Brand / firm

Randox Laboratories Ltd.

Sold / distributed

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, Mo…

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

CK MB Calibrator, Catalogue Number CK2393