Device recall
Z-1509-2012: ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an…
FDA device recall · Class II · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1509-2012 |
|---|---|
| Recall event | 61630 |
| Product | ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 ARCHITECT STAT Troponin-I is a chemiluminescent microparticle immunoassay… |
| Product code | MMI |
| Recalling firm | Abbott Laboratories |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 23, 2016 |
| 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