Device recall
Z-0538-2014: Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal…
FDA device recall · Class II · Remel Inc
Key facts
| Recall number (Z-number) | Z-0538-2014 |
|---|---|
| Recall event | 65476 |
| Product | Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and… |
| 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