Device recall
Z-1286-2023: CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro…
FDA device recall · Class II · Randox Laboratories
Key facts
| Recall number (Z-number) | Z-1286-2023 |
|---|---|
| Recall event | 91745 |
| Product | CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Catalogue number: CP3826 |
| Product code | DCK |
| Recalling firm | Randox Laboratories |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K953212 |
| FEI number | 3003059701 |
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