Randox Laboratories Ltd — Class II medical device recall Z-1461-2020
Terminated recall by Response Biomedical Corp., reported 2020-03-18, distributed nationwide. The form received three complaints related to the user obtaining a result that fell below the target range for
| Recall number | Z-1461-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Response Biomedical Corp., Vancouver, Canada |
| Recall initiated | 2019-03-15 |
| Classified | 2020-03-10 |
| Reported by FDA | 2020-03-18 |
| Terminated | 2022-06-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, CN, CO, DO, FR, IT, KW, MX, MY, RO, RS, RU, SA, SG, UA |
| Quantity | 543 units |
| Lot numbers | 070318, 4244CK |
| Model numbers | C2003-2, CQ5052 |
Product
Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318) IFU: "RAMP Cardiac Controls *** CAT. No.: C2003-2 *** Size: 3 x 3 ML". Product Usage: use in the quality control of cardiac marker assays run on the RAMP¿ platform.
Reason for recall
The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring, determined that liquid Cardiac Control has seen a decrease in CK-MB Levels of up to 57% signal loss within 11 months. Shelf-life of product is 24 months.
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-1461-2020. 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.