Device recall
Z-1461-2020: Randox Laboratories Ltd. Catalogue Number CQ5052, Lot Number 4244CK (relabeled…
FDA device recall · Class II · Response Biomedical Corp.
Key facts
| Recall number (Z-number) | Z-1461-2020 |
|---|---|
| Recall event | 84514 |
| 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… |
| Product code | JJY |
| Recalling firm | Response Biomedical Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 9, 2022 |
| 510(k) numbers | K110534 |
| FEI number | 3004205692 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database