CK MB Calibrator, Catalogue Number CK2393 recallZ-1097-2022 · Randox Laboratories Ltd. · initiated Mar 25, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Randox Laboratories Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-1097-2022
- Status
- Terminated
- Initiated by the company
- Mar 25, 2022
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 1,392
- Product code
- CGS
- 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 description
CK MB Calibrator, Catalogue Number CK2393
Code information (models, lots, serial numbers)
GTIN 05055273201451 Lot 4410CK
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CK-MB CAL CK2393Randox Laboratories Limited · Calibrator, Secondary1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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