Device recall
Z-2409-2021: Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)…
FDA device recall · Class II · Versea Diagnostics LLC
Key facts
| Recall number (Z-number) | Z-2409-2021 |
|---|---|
| Recall event | 88429 |
| Product | Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying… |
| Product code | QKO |
| Recalling firm | Versea Diagnostics LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 10, 2024 |
| FEI number | 3019891938 |
At a glance
- None 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