Device recall
Z-0742-2020: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100…
FDA device recall · Class II · Axis-Shield Diagnostics, Ltd.
Key facts
| Recall number (Z-number) | Z-0742-2020 |
|---|---|
| Recall event | 84043 |
| Product | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only. |
| Product code | LPS |
| Recalling firm | Axis-Shield Diagnostics, Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K083222 |
| FEI number | 3002808140 |
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