Lower risk Medical device recall · FDA · Published September 17, 2020

Quidel Sofia SARS Antigen FIA Test May Give False Positives - Recall

Quidel recalls Sofia SARS Antigen FIA tests that may give false positive results if viral transport media is used. Consumers should test directly from swabs without transport media.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0124-2021Medical device Quidel ›

Lower-risk recall

Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.

Take action

Contact the company

Recalling firmQuidel Corporation10165 McKellar Ct · San Diego, CA 92121-4201

✎ GovInfoNow plain-language explainer

Quidel is recalling its Sofia SARS Antigen FIA tests because using certain viral transport media can cause false positive results. The recall is for tests that were sold with specific instructions that no longer mention these media products. This matters because false positives could lead to unnecessary testing and anxiety. Read more at govinfonow.com/recall/64270-quidel-sofia-sars-antigen-fia-test-may-give-false-positives.

Source Summary by GovInfoNow · govinfonow.com/recall/64270-quidel-sofia-sars-antigen-fia-test-may-give-false-positives · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0124-2021

Cite this page

“Quidel Sofia SARS Antigen FIA Test May Give False Positives - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64270-quidel-sofia-sars-antigen-fia-test-may-give-false-positives. Based on FDA recall #Z-0124-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0124-2021%22&limit=1).

The FDA announced on September 17, 2020, that Quidel Corporation is recalling the Sofia SARS Antigen FIA Package Insert due to a hazard of false-positive results. The agency stated that use of specific viral transport media may lead to incorrect test outcomes.

How to tell if you have it

Brand: Quidel
Product: Sofia SARS Antigen FIA Package Insert
Lot codes: 1438900EN00 (03/20) and 1438901EN00 (05/20)
Units affected: 10,537

The hazard

According to the FDA, instructions for use in the package insert were updated to remove references to specific viral transport medium products and other viral transport media. The agency warned that using these specific products may result in false-positive results.

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 Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), the Meridian Bioscience Revogene C. difficile Test Recall (December 5, 2025), and the S. Typhi/Para Ty recall (November 22, 2025).

How to tell if you have this one

The Sofia SARS Antigen FIA test kit with model numbers 1438900EN00 (March 2020) or 1438901EN00 (May 2020).

Brand
Quidel
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Test Instructions
Ensure you are using the latest version of the package insert that no longer mentions viral transport media products.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 41 states.

FDA distribution: “U.S. Nationwide Distribution: NY, KS, TX, AL, FL, MN, CA, IL, MA, MS, PA, GA, NH, MO, VA, MI, OR, WV, OK, NV, CT, TN, MD, LA, AR, HI, NJ, KY, VT, IA, RI, NM, OH, IN, AK, SC, NC, AZ, SD, NE, WI, and.CO.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Sep 17, 2020Firm started the recall
Oct 19, 2020FDA classified it Class II
Oct 28, 2020Published in FDA’s Enforcement Report
Aug 9, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/64270-quidel-sofia-sars-antigen-fia-test-may-give-false-positives">Quidel Sofia SARS Antigen FIA Test May Give False Positives - Recall (GovInfoNow)</a>

Where this comes from

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-0124-2021 (September 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0124-2021 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.