Device recall
Z-1225-2017: Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
FDA device recall · Class II · Tosoh Bioscience, Inc.
Key facts
| Recall number (Z-number) | Z-1225-2017 |
|---|---|
| Recall event | 75727 |
| Product | Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing. |
| Product code | JCM |
| Recalling firm | Tosoh Bioscience, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 9, 2021 |
| 510(k) numbers | K071132, K131580 |
| FEI number | 1000123732 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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