Device recall
Z-1395-2011: SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand…
FDA device recall · Class II · Biosite Inc Dba Innovacon Inc.
Key facts
| Recall number (Z-number) | Z-1395-2011 |
|---|---|
| Recall event | 57715 |
| Product | SP Brand Strep A Cassette; Part Number: B1077-26; Lot #: STA0010037 The SP Brand Strep A Rapid Test Device is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is… |
| Product code | GTY |
| Recalling firm | Biosite Inc Dba Innovacon Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 26, 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