Lower riskMedical device recall · FDA · Published August 13, 2021
Quidel Lyra Direct SARS-CoV-2 Assay: False negatives with high viral loads
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.
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Contact the company
📍Recalling firmQuidel Corporation2005 E State St Ste 100 · Athens, OH 45701-2125
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/61951-quidel-lyra-direct-sars-cov-2-assay-false-negatives-with.
“Quidel Lyra Direct SARS-CoV-2 Assay: False negatives with high viral loads.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61951-quidel-lyra-direct-sars-cov-2-assay-false-negatives-with. Based on FDA recall #Z-2477-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2477-2021%22&limit=1).
The FDA announced on August 13, 2021, that Quidel Corporation is recalling the Lyra Direct SARS-CoV-2 Assay because revised instructions are needed to prevent false negative results in patients with high viral loads. The recall affects all lots of the product distributed worldwide.
How to tell if you have it
Brand: Quidel
Product: Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization - Ref: M124
Quantity: 81,910 kits
The hazard
The hazard is that specimens from patients with high SARS-CoV-2 viral loads may be falsely interpreted as negative if target amplification occurs prior to a cycle-threshold (Ct) value of 5 when using specific instruments. The affected instruments include 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.
Context
GovInfoNow's records show Quidel Corporation has had 10 other recalls on record since June 22, 2017. Other recent recalls of similar products include the BioFire Respiratory Panel 2.1 (June 24, 2026), the Meridian Bioscience Revogene C. difficile Test (December 5, 2025), and the Siemens Healthcare Syva EMIT 2000 Quinidine Assay (July 13, 2026).
How to tell if you have this one
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.
Brand
Quidel
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check PCR Machine Compatibility
Verify if your PCR machine is listed in the hazard description (e.g., Thermo Fisher QuantStudio 7 Pro).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including Puerto Rico and the countries of Canada, Panama, Virgin Islands, Germany, Honduras.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2477-2021 (August 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2477-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.