Quick Facts at a Glance
- Recall Date
- June 17, 2025
- Hazard Level
- HIGH
- Brand
- Quidel
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Quidel
- Product type
- Strep A Dipstick Test
- Model numbers
- 50T REF 20108, 25T REF 20125, 50T SCN REF 20108SC, 20108/30014613201083/709673, 709676, 709484, 709501, 709520 +7 more
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
June 17, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Dipstick strep A test has potential for false positive results.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Quidel Corporation or your healthcare provider for instructions. Notification method: Letter
About This Product
QuickVue Dipstick Strep A Test is a point-of-care test used to detect strep A infections. It is used by healthcare professionals in clinical settings.
Why This Is Dangerous
False positives can lead to unnecessary treatment, misdiagnosis, and misguided clinical decisions. This recall covers multiple lots with potential false positives.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Clinicians may perform unnecessary treatments or follow-up actions based on false positive results; patients may experience anxiety or unnecessary antibiotic exposure.
Practical Guidance
How to identify if yours is affected
- Check model references 50T REF 20108, 25T REF 20125, 50T SCN REF 20108SC
- Review UDI data 20108/30014613201083/709673 and similar codes
- Verify expiration dates around 2026
Where to find product info
FDA recall page and Quidel recall communications; lot numbers and expiration dates on packaging
What timeline to expect
Refunds or replacements are processed per recall instructions; typical timelines range weeks
If the manufacturer is unresponsive
- Document all contact attempts
- Escalate to consumer protection agencies if unresponsive
- Consult clinician for alternate testing during resolution
How to prevent similar issues
- Verify lot numbers and expiration dates before use
- Keep testing supplies in original packaging
- Follow manufacturer recalls promptly
- When buying, purchase from authorized sellers and check for recalls
Documentation advice
Keep recall notice, packaging photos, receipts, correspondence, and lot numbers
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Product Details
Product: QuickVue Dipstick Strep A Test Models/Refs: 50T REF 20108; 25T REF 20125; 50T SCN REF 20108SC Quantity: 22,470 units Distribution: Worldwide, including US states MA, NJ, MD, NC, SC, FL, TN, MS, MN, IL, MO, KS, LA, TX, CO, ID, CA, AK, NY, PA; countries Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, Turkey.
Reported Incidents
No specific injuries or incidents are described in the provided data.
Key Facts
- Worldwide distribution including US states listed
- Models: 50T REF 20108; 25T REF 20125; 50T SCN REF 20108SC
- UDI/lot data includes multiple codes with expiration dates in 2026
- Recall date 2025-06-17; status ACTIVE
- High hazard level
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Safety Guide
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