Device recall
Z-0513-06: ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains…
FDA device recall · Class II · Abbott Laboratories MPG
Key facts
| Recall number (Z-number) | Z-0513-06 |
|---|---|
| Recall event | 34297 |
| Product | ARCHITECT STAT Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 |
| Product code | MMI |
| Recalling firm | Abbott Laboratories MPG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 31, 2006 |
| 510(k) numbers | K041192 |
| FEI number | 1415939 |
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