Device recall
Z-0537-2014: Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping…
FDA device recall · Class II · Remel Inc
Key facts
| Recall number (Z-number) | Z-0537-2014 |
|---|---|
| Recall event | 65476 |
| Product | Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test system for use in the… |
| Product code | JTO |
| Recalling firm | Remel Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 12, 2014 |
| 510(k) numbers | K842828 |
| FEI number | 1924669 |
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