Device recall
Z-2071-2018: ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
FDA device recall · Class II · Tosoh Bioscience Inc
Key facts
| Recall number (Z-number) | Z-2071-2018 |
|---|---|
| Recall event | 79813 |
| Product | ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker |
| Product code | JHX |
| Recalling firm | Tosoh Bioscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 31, 2020 |
| 510(k) numbers | K913298 |
| FEI number | 3005529799 |
At a glance
- 1–9 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