Device recall
Z-2477-2021: Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra…
FDA device recall · Class II · Quidel Corporation
Key facts
| Recall number (Z-number) | Z-2477-2021 |
|---|---|
| Recall event | 88498 |
| Product | Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals… |
| Product code | QJR |
| Recalling firm | Quidel Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 2, 2023 |
| FEI number | 1000122536 |
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