Liquid Cardiac Control — Class II medical device recall Z-2575-2018
Terminated recall by Randox Laboratories Ltd., reported 2018-08-08, distributed in WV. The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials
| Recall number | Z-2575-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), N/A, Ireland |
| Recall initiated | 2018-06-08 |
| Classified | 2018-07-29 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2018-11-05 |
| Distributed | WV |
| Countries outside the US | AE, AU, CL, CN, DE, ES, GB, HU, IE, IT, NL, OM, PE, PL, SA, SK, VN |
| Reason classes | potency |
| Lot numbers | 4245CK |
| Model numbers | CQ5053 |
Product
Liquid Cardiac Control - Level 3, cat. no. CQ5053 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
Reason for recall
The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range could lead to a delay in reporting Troponin T results. If the failure occurs the operator may observe the quality control result for Troponin T falling outside range and/or increased imprecision for Quality Control monitoring.
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-2575-2018. 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.