Lower riskMedical device recall · FDA · Published April 6, 2026
Quidel QuickVue Strep A Test Recall: False Positive Risk
Quidel recalls QuickVue Dipstick Strep A Test (50T) with potential for false positives. Affected units include specific lot numbers and reference codes. Consumers should check their product details.
Product has the potential for false positive results
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Contact the company
📍Recalling firmQuidel Corporation10165 McKellar Ct · San Diego, CA 92121-4201
✎ GovInfoNow plain-language explainer
Quidel is recalling its QuickVue Dipstick Strep A Test (50 tests) due to a potential for false positive results. This could lead to incorrect diagnoses of strep throat, causing unnecessary anxiety or treatment. The recall affects specific lot numbers and reference codes. Read more at govinfonow.com/recall/49541-quidel-quickvue-strep-a-test-recall-false-positive-risk.
“Quidel QuickVue Strep A Test Recall: False Positive Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49541-quidel-quickvue-strep-a-test-recall-false-positive-risk. Based on FDA recall #Z-2169-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2169-2026%22&limit=1).
Quidel Corporation is recalling QuickVue Dipstick Strep A Test, 50T, REF 20108, due to the potential for false positive results, the Food and Drug Administration said on April 6, 2026.
How to tell if you have it
Brand: Quidel
Product: QuickVue Dipstick Strep A Test, 50T
REF: 20108
Lot Numbers: 225788, 228322, 233274
Units affected: 12,279
The hazard
The product has the potential for 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 Quidel QuickVue Strep A Dipstick Test Recall (June 17, 2025), Quidel InflammaDry MMP-9 Test Recall (March 5, 2024), and Quidel Sofia 2 Flu + SARS Antigen Test Recall (Jan. 3, 2024). Other recent recalls of similar products include Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), and Altruan Clearest Strep-A Cassette Test Recall (Dec. 19, 2025).
How to tell if you have this one
Check the product's reference code (20108) and lot numbers (225788, 228322, 233274) on the packaging. The test is for strep A detection and comes in a 50-test package.
Brand
Quidel
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the reference code 20108 and lot numbers 225788, 228322, or 233274 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Florida, Idaho, Illinois, Louisiana, Maryland, Massachusetts, Minnesota, Missouri, New York, Pennsylvania, South Carolina, Tennessee, Texas, Virginia.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2169-2026 (April 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2169-2026 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.