Liquid Cardiac Control — Class II medical device recall Z-0380-2019
Terminated recall by Randox Laboratories Ltd., reported 2018-11-14, distributed in IN, NY, PR, WV. Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 201
| Recall number | Z-0380-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories Ltd., Crumlin (North), Ireland |
| Recall initiated | 2018-10-02 |
| Classified | 2018-11-02 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2019-05-30 |
| Distributed | IN, NY, PR, WV |
| Quantity | 1,763 |
| Reason classes | potency |
Product
Liquid Cardiac Control, CQ5051
Reason for recall
Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no longer suitable for the control of the Troponin T assay due to unacceptable variation between vials.
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-0380-2019. 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.