Device recall
Z-0474-2015: ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6…
FDA device recall · Class II · Abbott Ireland Diagnostics Division
Key facts
| Recall number (Z-number) | Z-0474-2015 |
|---|---|
| Recall event | 69289 |
| Product | ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate… |
| Product code | CDP |
| Recalling firm | Abbott Ireland Diagnostics Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 23, 2016 |
| 510(k) numbers | K983439 |
| FEI number | 3005094123 |
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