Z-1097-2022Class III

CK MB Calibrator, Catalogue Number CK2393

Name: Z-1097-2022 CK MB Calibrator, Catalogue Number CK2393
Creator: Randox Laboratories Ltd.
Published: 2022-03-25
License: https://open.fda.gov/license/

Randox Laboratories, Limited / initiated 2022-03-25 / Terminated / root cause: manufacturing process

FDA source

Randox Laboratories Ltd. began a recall of CK MB Calibrator, Catalogue Number CK2393 on 2022-03-25. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1097-2022
Classification: Class III
Status: Terminated
Initiated: 2022-03-25
Posted: 2022-05-16
Terminated: 2023-12-26
Recalling firm: Randox Laboratories, Limited
Product: CK MB Calibrator, Catalogue Number CK2393
Product code: CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by 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].
Quantity in commerce: 1,392
Distribution: 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.
Product codes and lots: GTIN 05055273201451 Lot 4410CK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1097-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1097-2022	Class III	Terminated	Voluntary: Firm initiated	2022-05-25	2022-05-16

Product code CGS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)