Randox Liquid Cardiac Controls Catalogue Numbers CQ5053 — Class II medical device recall Z-0414-2020
Terminated recall by Randox Laboratories, Limited, reported 2019-11-27, distributed in CA, DE, GA, IN, NJ, NY, PR, WV. Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrea
| Recall number | Z-0414-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Limited, Crumlin, N/A, United Kingdom |
| Recall initiated | 2019-10-04 |
| Classified | 2019-11-15 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2020-07-06 |
| Distributed | CA, DE, GA, IN, NJ, NY, PR, WV |
| Quantity | 6,702 |
| UPC / GTIN / UDI-DI | 05055273207460 |
| Lot numbers | 4245CK |
| Model numbers | CQ5053 |
| Expiration dates | 2019-11-28, 2020-06-28 |
Product
Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
Reason for recall
Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
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-0414-2020. 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.