Device recall
Z-1048-04: ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers…
FDA device recall · Class II · Abbott Laboratories HPD/ADD/GPRD
Key facts
| Recall number (Z-number) | Z-1048-04 |
|---|---|
| Recall event | 29352 |
| Product | ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit); Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA |
| Product code | GTZ |
| Recalling firm | Abbott Laboratories HPD/ADD/GPRD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2004 |
| 510(k) numbers | K971522 |
| FEI number | 1415939 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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