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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2477-2021 |
Event ID | 88498 |
Event 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 |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide distribution including Puerto Rico and the countries of Canada, Panama, Virgin Islands, Germany, Honduras. |
Quantity | 81,910 kits |
Recall 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. |
Device Classification | 20210922 |
Device Code Info | All lots |
Center Classification Date | 20210915 |
Recall Initiation Date | 20210813 |
Recalling Firm | Quidel Corporation |
Initial Notification | |
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