Device recall
Z-2746-2026: ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative…
FDA device recall · Class II · Tosoh Bioscience Inc
Key facts
| Recall number (Z-number) | Z-2746-2026 |
|---|---|
| Recall event | 99210 |
| Product | ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers, Model Number 0025204 |
| Product code | CDZ |
| Recalling firm | Tosoh Bioscience Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K023091 |
| 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