Device recall
Z-0007-2008: 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of…
FDA device recall · Class III · Tosoh Bioscience Inc
Key facts
| Recall number (Z-number) | Z-0007-2008 |
|---|---|
| Recall event | 38494 |
| Product | 4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic. |
| Product code | JJX |
| Recalling firm | Tosoh Bioscience Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 7, 2010 |
| 510(k) numbers | K924853-DECEMBER |
| 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