Recall Z-2477-2021— Quidel Corporation

Class II FDA medical device recall by Quidel Corporation, initiated 2021-08-13, terminated 2023-11-02. FDA's recall record names no specific 510(k) clearance for this event. 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..

Recalling firm

Quidel Corporation

Classification

Class II

Status

Terminated

Initiated

2021-08-13

Terminated

2023-11-02

Firm location

Athens, OH, United States

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