Device recall
Z-0726-03: Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with…
FDA device recall · Class II · Abbott Laboratories HPD/ADD
Key facts
| Recall number (Z-number) | Z-0726-03 |
|---|---|
| Recall event | 25689 |
| Product | Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350; Abbott Diagnostics, a Division of… |
| Product code | LOJ |
| Recalling firm | Abbott Laboratories HPD/ADD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 4, 2003 |
| PMA numbers | P820060 |
| FEI number | 1415939 |
At a glance
- None 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