CK MB Calibrator — Class III medical device recall Z-1097-2022
Terminated recall by Randox Laboratories Ltd., reported 2022-05-25, distributed in GA, PR, WV. Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a
| Recall number | Z-1097-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2022-03-25 |
| Classified | 2022-05-16 |
| Reported by FDA | 2022-05-25 |
| Terminated | 2023-12-26 |
| Distributed | GA, PR, WV |
| Countries outside the US | BD, CH, CN, CO, CR, DE, EG, FR, GB, GH, GR, HK, HR, IN, IQ, IT, KR, LT, MA, MT, MX, MY, NG, NP, PH, PK, PL, RO, RU, SA, TH, TR, UY, VN |
| Quantity | 1,392 |
| UPC / GTIN / UDI-DI | 05055273201451 |
| Lot numbers | 4410CK |
| Model numbers | CK2393 |
Product
CK MB Calibrator, Catalogue Number CK2393
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1097-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.