Device recall
Z-1344-2013: Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN…
FDA device recall · Class III · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-1344-2013 |
|---|---|
| Recall event | 49026 |
| Product | Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for… |
| Product code | JHI |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 28, 2013 |
| 510(k) numbers | K993317 |
| 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