FDA Device

CK MB Calibrator, Catalogue Number CK2393

Hazard

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.

What You Should Do

Remedy

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.

Products

CK MB Calibrator, Catalogue Number CK2393
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
UPC
GTIN 05055273201451 Lot 4410CK

Units Affected

1,392