Device recall
Z-0224-2020: HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide…
FDA device recall · Class II · Hycor Biomedical LLC
Key facts
| Recall number (Z-number) | Z-0224-2020 |
|---|---|
| Recall event | 83853 |
| Product | HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA kit, Part# 74155; and (2) HYTEC Specific IgG EIA Kit, Part# 74114. |
| Product code | DHB |
| Recalling firm | Hycor Biomedical LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K081217, K941278 |
| FEI number | 1000125787 |
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