FDA Device recall Z-1461-2020
Randox Laboratories Ltd
- FDA Device
- Class II
- terminated
- Published 2020-03-18
On 2020-03-18 the FDA classified a Class II recall of Randox Laboratories Ltd by Response Biomedical, citing 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. Vi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1461-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-15 |
| Published | 2020-03-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Response Biomedical |
| Distribution | US |
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
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.
Identifiers
| code_info | Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number…Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled as Response Biomedical Catalogue Number C2003-2, Lot #070318). UDI Code: (01) 1 0627966 00508 4 (10) 070318 (17)300919 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1461-2020%22
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