Device recall
Z-1812-2018: Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN…
FDA device recall · Class II · Tosoh Bioscience Inc
Key facts
| Recall number (Z-number) | Z-1812-2018 |
|---|---|
| Recall event | 79708 |
| Product | Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718 The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay |
| Recalling firm | Tosoh Bioscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2020 |
| 510(k) numbers | K100304 |
| 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