Quidel recalls Lyra Direct SARS-CoV-2 Assay due to potential false negatives in high viral load samples when used with certain PCR machines. Affected units may need retesting or alternative methods.
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.
Quidel is recalling its Lyra Direct SARS-CoV-2 Assay because it can give false negative results for patients with very high SARS-CoV-2 viral loads when used with specific PCR machines. This means some people might be incorrectly told they don't have COVID-19 when they actually do.
The assay might show a negative result for patients with very high SARS-CoV-2 viral loads because the test amplifies the virus too quickly before reaching a detectable threshold. This could lead to false negatives when used with specific PCR machines like the Thermo Fisher QuantStudio 7 Pro.
Healthcare providers using the Lyra Direct SARS-CoV-2 Assay with certain PCR machines may be affected. Patients with high viral loads could be misdiagnosed as negative.
The Lyra Direct SARS-CoV-2 Assay with Emergency Use Authorization Ref: M124. It was sold for use by healthcare providers testing for COVID-19.
Verify if your PCR machine is listed in the hazard description (e.g., Thermo Fisher QuantStudio 7 Pro).
Yes, the test may show a negative result for patients with very high SARS-CoV-2 viral loads when used with specific PCR machines.
The test can cause false negatives with Thermo Fisher QuantStudio 7 Pro, Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500, Bio-Rad CFX96 Touch, Roche LightCycler LC 480 II, cobas z 480, or Qiagen Rotor-Gene MDx.
No, the recall does not require stopping use. Healthcare providers should check their PCR machine compatibility and consider retesting if false negatives are suspected.
We’ve drafted a message you can send Quidel to request your refund or repair — edit it as you like.
Subject: Recall Z-2477-2021 — Quidel Quidel Hello, I own a Quidel that is covered by recall Z-2477-2021 from Quidel. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
