Quidel QuickVue Strep A Dipstick Test Recall: False Positive Risk
Quidel recalls specific QuickVue Strep A dipstick tests due to potential false positives. Affected lots may give incorrect results, but no safety risks. Consumers should check their lot numbers.
Lower-risk recall
Dipstick strep A test has potential for false positive results.
Contact the company
What happened, in plain English
Quidel is recalling certain QuickVue Strep A dipstick tests that may show false positive results. This means the test could incorrectly indicate strep throat when it's not present, leading to unnecessary treatment or anxiety. The recall does not involve safety risks like injury or fire. Read more at govinfonow.com/recall/52030-quidel-quickvue-strep-a-dipstick-test-recall-false-positive-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/52030-quidel-quickvue-strep-a-dipstick-test-recall-false-positive-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2545-2025
Cite this page
“Quidel QuickVue Strep A Dipstick Test Recall: False Positive Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52030-quidel-quickvue-strep-a-dipstick-test-recall-false-positive-risk. Based on FDA recall #Z-2545-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2545-2025%22&limit=1).
Why it’s dangerous
The dipstick test can sometimes show a positive result for strep A when there is no actual infection. This false positive may lead to unnecessary antibiotic use or anxiety about strep throat. The test is designed for home use and does not pose physical safety risks.
Who’s affected
People who purchased the recalled QuickVue Strep A dipstick tests (50T, 25T, or 50T SCN versions) are affected. Those most at risk are individuals using the test for strep throat screening who might receive inaccurate results.
How to tell if you have this one
Check the lot number on the test packaging. The recalled items have specific lot numbers listed in the recall notice, including expiration dates from January to February 2026. The product names include 'QuickVue: Dipstick Strep A Test' with quantities of 25T or 50T.
- Brand
Quidel- Category
Medical device
What to do — step by step
Check Lot Number
Look for the lot number on the test packaging to determine if it is affected. The recall includes specific lot numbers with expiration dates from January to February 2026.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 20 states.
FDA distribution: “Worldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC, FL, TN, MS, MN, IL, MO, KS, LA, TX, CO, ID, CA, AK, NY, PA and the countries of Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, Turkey.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, California, Colorado, Florida, Idaho, Illinois, Kansas, Louisiana, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the test?
No, the recall does not require stopping use. The test can still be used, but you should check the lot number to ensure it is not affected.
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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-2545-2025 (June 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2545-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.