Device recall
Z-0601-2019: Hemoglobin A1c Control, Part no. 220232 for use as quality control material to…
FDA device recall · Class III · Tosoh Bioscience Inc
Key facts
| Recall number (Z-number) | Z-0601-2019 |
|---|---|
| Recall event | 81188 |
| Product | Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. |
| Product code | LCP |
| Recalling firm | Tosoh Bioscience Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 16, 2020 |
| 510(k) numbers | K021484 |
| FEI number | 3005529799 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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