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Quidel Corporation Recall 88498

Description: 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

Quidel Corporation Recall 88498 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2477-2021
Event ID88498
Event DescriptionLyra 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
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution including Puerto Rico and the countries of Canada, Panama, Virgin Islands, Germany, Honduras.
Quantity81,910 kits
Recall ReasonRevised 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.
Device Classification20210922
Device Code InfoAll lots
Center Classification Date20210915
Recall Initiation Date20210813
Recalling FirmQuidel Corporation
Initial Notification E-Mail
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