Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124 — Class II medical device recall Z-2477-2021
Terminated recall by Quidel Corporation, reported 2021-09-22, distributed nationwide. Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral loads to be fal
| Recall number | Z-2477-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quidel Corporation, Athens, OH, United States |
| Recall initiated | 2021-08-13 |
| Classified | 2021-09-15 |
| Reported by FDA | 2021-09-22 |
| Terminated | 2023-11-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, HN, PA |
| Quantity | 81,910 kits |
| Model numbers | M124 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2477-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.