Device recall
Z-1075-2012: Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand…
FDA device recall · Class II · Alere San Diego
Key facts
| Recall number (Z-number) | Z-1075-2012 |
|---|---|
| Recall event | 60959 |
| Product | Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand Name (Catalog Number): ACON Rapid Device Strep A Twist (IST-502T); CONSULT Diagnostics Strep A Twist, PSS (5005); Medi-Lab Performance Strep A Test-Twist, McKesson (32-502T); MooreBrand Strep A Twist Cassette, Moore… |
| Product code | GTY |
| Recalling firm | Alere San Diego |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2012 |
| 510(k) numbers | K023766 |
| 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