# FDA recall Z-2477-2021

> **Quidel Corporation** · Class II · device recall initiated 2021-08-13.

## 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.

## Distribution

Worldwide distribution - US Nationwide distribution including Puerto Rico and the countries of Canada, Panama, Virgin Islands, Germany, Honduras.

## Key facts

- **Recall number:** Z-2477-2021
- **Recalling firm:** Quidel Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-13
- **Report date:** 2021-09-22
- **Termination date:** 2023-11-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2477-2021

## Citation

> AI Analytics. FDA recall Z-2477-2021. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-2477-2021. Source: US FDA. Licensed CC0.

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