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Lower risk Medical device recall · FDA · Published January 3, 2024

Quidel Sofia 2 Flu + SARS Antigen Test: Incorrect Expiration Dates

Quidel recalls a specific lot of Sofia 2 Flu + SARS Antigen FIA tests with incorrect expiration dates. The kits may expire before the actual shelf life, potentially leading to inaccurate results. Affected units have lot number 709083.

🇺🇸 FDA recall #Z-1086-2024Medical deviceQuidel ›
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Recalling firmQuidel Corporation2285 Rutherford Rd · Carlsbad, CA 92008-8815
✎ GovInfoNow plain-language explainer

Quidel is recalling a specific lot (709083) of Sofia 2 Flu + SARS Antigen FIA tests because they were labeled with incorrect expiration dates. Using these tests after the wrong expiration date could lead to inaccurate results, which might affect test reliability. Read more at govinfonow.com/recall/56409-quidel-sofia-2-flu-sars-antigen-test-incorrect-expiration-dates.

Source Summary by GovInfoNow · govinfonow.com/recall/56409-quidel-sofia-2-flu-sars-antigen-test-incorrect-expiration-dates · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1086-2024

Cite this page

“Quidel Sofia 2 Flu + SARS Antigen Test: Incorrect Expiration Dates.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56409-quidel-sofia-2-flu-sars-antigen-test-incorrect-expiration-dates. Based on FDA recall #Z-1086-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1086-2024%22&limit=1).

The FDA announced on Jan. 3, 2024, that Quidel Corporation is recalling one lot of The Sofia 2 Flu + SARS Antigen FIA diagnostic kits due to incorrect expiration dates. The kits were distributed nationwide and in specific states including FL, TN, IL, LA, NY, and IN.

How to tell if you have it

  • Brand: Quidel
  • Product: The Sofia 2 Flu + SARS Antigen FIA
  • Lot code: 709083
  • UDI-DI: 30014613339229
  • Quantity: 312 Kits

The hazard

The kits contain pouched cassettes and are labeled with expiration dates of May 31, 2025, and April 30, 2025, respectively. The correct expiration date for both the pouches and the kits is September 12, 2024. The issue was discovered on November 28, 2023, by a supply chain employee who determined the kits had expiration dates beyond the FDA authorized shelf life.

Context

GovInfoNow's records show Quidel Corporation has 10 other recalls on record since June 22, 2017. Other recent recalls of similar products include Quidel QuickVue Strep A Test Recall (April 6, 2026), Quidel QuickVue Strep A Dipstick Test Recall (June 17, 2025), and Quidel InflammaDry MMP-9 Test Recall (March 5, 2024). Other recent recalls of similar products include Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), Healthmark ProChek-II (July 29, 2026), and Cook Medical Wayne Pneumothorax Set (March 5, 2026).

How to tell if you have this one

Check for the lot number 709083 on the test kit packaging. The kits were sold with incorrect expiration dates of May 31, 2025 and April 30, 2025, but the correct expiration date is September 12, 2024.

  • Brand
    Quidel
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Expiration Date

    Verify the expiration date on the test kit packaging. If it shows May 31, 2025 or April 30, 2025, it is part of the recalled lot.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 6 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: nationwideMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: named in the noticeLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of FL, TN, IL, LA, NY, IN.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Illinois, Indiana, Louisiana, New York, Tennessee.

Recall timeline

FDA published this recall 49 days after the firm started it.

1. Firm started the recall: Jan 3, 202412. FDA classified it Class II: Feb 14, 202423. Published in FDA’s Enforcement Report: Feb 21, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-1086-2024 (January 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1086-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA