Lower riskMedical device recall · FDA · Published March 25, 2022
Randox CK MB Calibrator Recall: 6% Calibration Shift Risk
Randox recalls CK MB Calibrator model CK2393 (lot 441:0CK) due to potential 6% calibration shift affecting test accuracy. Affected units may need recalibration or replacement.
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.
“Randox CK MB Calibrator Recall: 6% Calibration Shift Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60892-randox-ck-mb-calibrator-recall-6-calibration-shift-risk. Based on FDA recall #Z-1097-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1097-2022%22&limit=1).
The FDA announced on March 25, 2022, that Randox Laboratories Ltd. voluntarily recalled CK MB Calibrator, Catalogue Number CK2393, due to a realignment issue. This defect causes a positive shift of approximately 6% in quality controls and patient samples. The recall affects 1,392 units distributed domestically and internationally.
How to tell if you have it
Brand: Randox
Product: CK MB Calibrator, Catalogue Number CK2393
UPC: 05055273201451
Lot Code: 4410CK
The hazard
Randox Laboratories realigned the CK-MB Calibrator, lot number 4410CK. Using this recalibrated product causes a positive shift of approximately 6% with both quality controls and patient samples.
Context
GovInfoNow's records show Randox Laboratories Ltd. has had 49 other recalls on record since June 7, 2017. Recent brand recalls include a Cystatin C Reagent recall on June 7, 2024, for missing FDA 510(k) clearance, and an Evidence MultiSTAT Software v3.7 recall on April 5, 2024, involving light leak risks. Other recent recalls of similar products include a Beckman Coulter Access Total T4 Calibrator recall on March 16, 2026, for false low results risk, and Medline Convenience Kits recalls on January 7, 2026, regarding sterility risks from calibration issues.
How to tell if you have this one
Check for the model CK2393 with lot number 4410CK on the device or packaging. The product was sold with GTIN 05055273201451.
Brand
Randox
Product
CK MB Calibrator, Catalogue Number CK2393
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Calibration Value
Verify the current calibration value on the device matches the manufacturer's specifications for model CK2393.
Where it went and when
Where it was distributed
Distributed in Puerto Rico and West Virginia, and outside the U.S.
Listed by the agency
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Puerto Rico, West Virginia.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1097-2022 (March 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1097-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.