Device recall
Z-1126-2021: Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)…
FDA device recall · Class II · Confirm Biosciences Inc
Key facts
| Recall number (Z-number) | Z-1126-2021 |
|---|---|
| Recall event | 87263 |
| Product | Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated… |
| Product code | QKO |
| Recalling firm | Confirm Biosciences Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 13, 2022 |
| FEI number | 3006048451 |
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