Device recall
Z-1074-2012: Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog…
FDA device recall · Class II · Alere San Diego
Key facts
| Recall number (Z-number) | Z-1074-2012 |
|---|---|
| Recall event | 60959 |
| Product | Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Rapid Test Device (IST-502); BD Directigen EZ Group A Strep, Becton Dickinson (256032); Clearview… |
| Product code | GTY |
| Recalling firm | Alere San Diego |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2012 |
| 510(k) numbers | K031784 |
| FEI number | 1000125596 |
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