Device recall
Z-1569-2008: Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and…
FDA device recall · Class III · Abbott Laboratories
Key facts
| Recall number (Z-number) | Z-1569-2008 |
|---|---|
| Recall event | 47236 |
| Product | Architect Free T4 MasterCheck; a single (specified) analyte control (assayed and unassayed); list 6C50-05. Intended for use in the verification of sensitivity, calibration linearity, and reportable range on the Abbott ARCHITECT i System. Abbott Laboratories, Abbott Park, IL 60064 |
| Product code | JJX |
| Recalling firm | Abbott Laboratories |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 5, 2008 |
| 510(k) numbers | K984070 |
| 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