Device recall
Z-0799-2019: ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR…
FDA device recall · Class II · Abbott Ireland Diagnostics Division
Key facts
| Recall number (Z-number) | Z-0799-2019 |
|---|---|
| Recall event | 81402 |
| Product | ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma. |
| Product code | CDP |
| Recalling firm | Abbott Ireland Diagnostics Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2020 |
| FEI number | 3005094123 |
At a glance
- None 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