Device recall
Z-2067-2018: ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
FDA device recall · Class II · Tosoh Bioscience Inc
Key facts
| Recall number (Z-number) | Z-2067-2018 |
|---|---|
| Recall event | 79813 |
| Product | ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker |
| Product code | LTJ |
| Recalling firm | Tosoh Bioscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 31, 2020 |
| PMA numbers | P910065 |
| FEI number | 3005529799 |
At a glance
- None Linked 510(k)s
- 10–99 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