Device recall
Z-0558-06: TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for…
FDA device recall · Class III · Tosoh Bioscience Inc
Key facts
| Recall number (Z-number) | Z-0558-06 |
|---|---|
| Recall event | 34547 |
| Product | TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for the quantitative measurement of Total Triiodothyronine Human Serum. Each box of product contains 5 trays of 20 test cups per tray. Each tray is packaged in a foil pack. Both the box and foil packs have product labels. |
| Product code | CDP |
| Recalling firm | Tosoh Bioscience Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 24, 2008 |
| 510(k) numbers | K936229 |
| FEI number | 3005529799 |
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