📍Recalling firmQuidel Corporation10165 McKellar Ct · San Diego, CA 92121-4201
✎ GovInfoNow plain-language explainer
Quidel is recalling its Sofia SARS Antigen FIA test kits (model 20374) because they can produce false positive results. This means the test might incorrectly show a positive result for SARS when there's no infection, which could lead to unnecessary anxiety or actions. Read more at govinfonow.com/recall/64144-quidel-sofia-sars-antigen-fia-false-positive-results-recall.
“Quidel Sofia SARS Antigen FIA: False Positive Results Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64144-quidel-sofia-sars-antigen-fia-false-positive-results-recall. Based on FDA recall #Z-0428-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0428-2021%22&limit=1).
The FDA announced on September 25, 2020, that Quidel Corporation voluntarily recalled QUIDEL Sofia SARS Antigen FIA IVD REF 20374 due to the risk of false positive results. The agency issued recall number Z-0428-2021 for the Class II device.
How to tell if you have it
Brand: Quidel
Product: QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Model Number: 20374
Lot Number: 706142
UPC A GTIN-12: 0 14613 33908 2
Units affected: 8,628 kits
The hazard
The recall addresses false positive results from the device. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Quidel Corporation has 10 other recalls on record since June 22, 2017. Other recent recalls of similar products include Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), Sperm Ab ELISA Test Kit Recall (July 2, 2026), and Tosoh ST AIA-Pack Testosterone Recall (June 12, 2026).
How to tell if you have this one
Check the model number on the test kit, which should be 20374. Look for lot numbers between 706142 and 166817. The product was sold with UPC A GTIN-12: 0 14613 33908 2.
Brand
Quidel
Product
QUIDEL Sofia SARS Antigen FIA IVD REF 20374
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Number
Look for model number 20374 on the test kit packaging.
Verify Lot Number
Ensure the lot number is between 706142 and 166817 to confirm it's affected.
Where it went and when
Where it was distributed
Distributed in 23 states.
Listed by the agency
Not listed
FDA distribution: “U.S.: AL, AR, AZ, CA, FL, GA, IN, LA, MO, MS, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Florida, Georgia, Indiana, Louisiana, Mississippi, Missouri, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 4 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-0428-2021 (September 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0428-2021 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.