Device recall
Z-0855-2007: ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25…
FDA device recall · Class I · Abbott Laboratories MPG
Key facts
| Recall number (Z-number) | Z-0855-2007 |
|---|---|
| Recall event | 37570 |
| Product | ARCHITECT STAT Troponin-I Reagent; list numbers 2K41-20 (400 test kit), 2K41-25 (100 test kit) and 2K41-30 (2000 test kit); each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 |
| Product code | MMI |
| Recalling firm | Abbott Laboratories MPG |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 16, 2008 |
| 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