Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland CK MB Calibrator, Catalogue Number CK2393 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CK MB Calibrator, Catalogue Number CK2393
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
GTIN 05055273201451 Lot 4410CK
Products Sold
GTIN 05055273201451 Lot 4410CK
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling CK MB Calibrator, Catalogue Number CK2393 due to Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, WV, PR
Page updated: Jan 10, 2026