Device recall
Z-0501-2007: IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7…
FDA device recall · Class II · Abbott Laboratories MPG
Key facts
| Recall number (Z-number) | Z-0501-2007 |
|---|---|
| Recall event | 37002 |
| Product | IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd… |
| Product code | NRP |
| Recalling firm | Abbott Laboratories MPG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 18, 2008 |
| 510(k) numbers | K042411 |
| 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