The Recall Desk
HighFDA (Devices)·Z-2545-2025·Announced 2025-09-17

QuickVue Dipstick Strep A Test Recall: False Positive Results

Quidel Corporation is recalling QuickVue Dipstick Strep A Test kits due to potential for false positive results. Affected units were distributed nationwide and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Although no illnesses or injuries have been reported, false positive results on a diagnostic test represent a risk-of-harm scenario. Incorrect test results could lead to unnecessary medical treatment, meeting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Quidel Corporation is recalling specific lots of its QuickVue Dipstick Strep A Test (models REF 20108, 20125, and 20108SC). The tests have a potential for false positive results, which could lead to incorrect diagnoses.

Approximately 22,470 affected units were distributed worldwide, including to healthcare facilities in multiple U.S. states (Massachusetts, New Jersey, Maryland, North Carolina, South Carolina, Florida, Tennessee, Mississippi, Minnesota, Illinois, Missouri, Kansas, Louisiana, Texas, Colorado, Idaho, California, Alaska, New York, and Pennsylvania) and internationally to Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, and Turkey.

Healthcare providers and patients who have used affected lots should consult with their healthcare provider, particularly if test results were used for diagnosis or treatment decisions. The recall affects specific lot codes with expiration dates ranging from January 9, 2026 to February 12, 2026.

The recalled product

Product
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Manufacturer
Quidel Corporation
Category
Medical Device — Diagnostic Test
Hazard
  • false-positive-results

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • REF/UDI-DI/Lot(Expiration): 20108/30014613201083/709673(05-FEB-2026)
  • 709676(05-FEB-2026)
  • 709484(09-JAN-2026)
  • 709501(09-JAN-2026)
  • 709520(16-JAN-2026)
  • 709535(16-JAN-2026)
  • 20125/30014613201250/709487(09-JAN-2026)
  • 709503(16-JAN-2026)
  • 709509(16-JAN-2026)
  • 709684(12-FEB-2026)
  • 20108SC/0130014613330073/709485(09-JAN-2026)
  • 709502(16-JAN-2026)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category