Device recall
Z-0745-2020: AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of…
FDA device recall · Class III · Tosoh Smd Inc
Key facts
| Recall number (Z-number) | Z-0745-2020 |
|---|---|
| Recall event | 84299 |
| Product | AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706 |
| Product code | CDD |
| Recalling firm | Tosoh Smd Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 1, 2020 |
| 510(k) numbers | K964348 |
| 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