The Randox Liquid Cardiac Controls Level 1 — Class II medical device recall Z-0762-2017
Terminated recall by Randox Laboratories, reported 2016-12-21. An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Ra
| Recall number | Z-0762-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Antrim, United Kingdom |
| Recall initiated | 2016-09-16 |
| Classified | 2016-12-14 |
| Reported by FDA | 2016-12-21 |
| Terminated | 2018-04-11 |
| Quantity | 2,817 |
| Reason classes | specification failure |
Product
The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only.
Reason for recall
An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roche e411, BioMerieux Vidas, and Siemens Centaur Classic methods.
Machine access
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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.