Quidel recalls Lyra SARS-CoV-2 Assay (M120) reagents with specific lot numbers due to rare false negative results when viral load is high and Ct values drop below 5.
In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users.
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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 specific lots of their Lyra SARS-CoV-2 Assay (M120) test reagents. The recall is for rare cases where high viral loads might cause false negative results if the test shows Ct values of 5 or lower. This could lead to incorrect negative results for SARS-CoV-2 infections. Read more at govinfonow.com/recall/62695-quidel-lyra-sars-cov-2-assay-m120-recall-false-negative.
“Quidel Lyra SARS-CoV-2 Assay (M120) Recall: False Negative Risk with Low Ct Values.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62695-quidel-lyra-sars-cov-2-assay-m120-recall-false-negative. Based on FDA recall #Z-1928-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1928-2021%22&limit=1).
The FDA announced on April 27, 2021, that Quidel Corporation is recalling its Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent. The agency stated the recall addresses a risk of false negative results for patients with high viral loads. This voluntary Class I recall affects 29,787 kits distributed worldwide.
How to tell if you have it
Brand: Quidel
Product: Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Distribution: Worldwide; US states AL, CA, CT, DC, FL, ID, IN, MA, MI, MO, NM, NY, OH, SC, TN, TX, WA; Canada, Saudi Arabia, United Kingdom
The hazard
According to the FDA, patients infected with a high viral load of SARS-CoV-2 may have samples that generate cycle threshold (Ct) values less than or equal to 5 when used with certain amplification and detection platforms. These specimens could be falsely interpreted as negative if target amplification occurs prior to a Ct value of 5. The record states there have been no formal complaints of false negative results with Ct values less than 5 from users.
Context
GovInfoNow's records show Quidel Corporation has 10 other recalls on record since June 22, 2017. Other recent recalls of similar products include the Quidel QuickVue Strep A Test Recall (April 6, 2026), the Quidel QuickVue Strep A Dipstick Test Recall (June 17, 2025), and the Quidel InflammaDry MMP-9 Test Recall (March 5, 2024). Other recent recalls of similar products include the Meridian Bioscience Revogene C. difficile Test Recall (December 5, 2025), the Hologic Aptima HPV Assay Kit Recall (February 18, 2026), and the Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026).
How to tell if you have this one
Check the lot number on the reagent packaging. The affected lots include specific numbers like 031620A, 031620B, 031620C, 032320, and others listed in the recall notice.
Brand
Quidel
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number on the reagent packaging to determine if it is affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AL, CA, CT, DC, FL, ID, IN, MA, MI, MO, NM, NY, OH, SC, TN, TX, WA and the countries of Canada, Saudi Arabia, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Connecticut, District of Columbia, Florida, Idaho, Indiana, Massachusetts, Michigan, Missouri, New Mexico, New York, Ohio, South Carolina, Tennessee, Texas, Washington.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
What should I do if I have the affected lot numbers?
Check the lot number on the reagent packaging. If it matches the listed affected lots, you should stop using it and contact Quidel for further instructions.
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-1928-2021 (April 27, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1928-2021 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.