FDA Device recall Z-2477-2021
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124
- FDA Device
- Class II
- terminated
- Published 2021-09-22
On 2021-09-22 the FDA classified a Class II recall of Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124 by Quidel, citing revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target amplification occurs prior to….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2477-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-13 |
| Published | 2021-09-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Quidel |
| Distribution | US |
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 suspected of COVID-19 by their healthcare provider
Reason
Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be falsely interpreted as negative if target amplification occurs prior to a cycle-threshold (Ct) value of 5 when using the Thermo Fisher QuantStudio 7 Pro, the Applied Biosystems 7500 Fast Dx, the Applied Biosystems 7500, the Bio-Rad CFX96 Touch", the Roche LightCycler LC 480 II/ cobas z 480, or the Qiagen Rotor-Gene¿ MDx.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2477-2021%22
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