Recall archive / FDA device enforcement
CK MB Calibrator, Catalogue Number CK2393 — FDA record Z-1097-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- CK MB Calibrator, Catalogue Number CK2393
- Reason
- 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.
- Classification
- Class III
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 1,392
- Agency-reported status
- Terminated
- Source record identifier
- Z-1097-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 05055273201451 Lot 4410CK |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 25, 2022
- Recall initiation date
- Mar 25, 2022
- Center classification date
- May 16, 2022
- Termination date
- Dec 26, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.