HIGH

Quidel Recalls Dipstick Strep A Test Over False Positive Risk

Quidel Corporation recalled 22,470 Dipstick Strep A Tests on June 17, 2025, due to potential false positive results. The recall affects tests distributed in multiple U.S. states and internationally. Patients and healthcare providers must stop using the device immediately.

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

Product Details

The recall includes QuickVue Dipstick Strep A Test models: 50T, REF: 20108; 25T, REF: 20125; and 50T, SCN, REF: 20108SC. The tests were distributed in the U.S. and countries such as Canada, Italy, and Sweden.

The Hazard

The Dipstick Strep A Test may yield false positive results. This risk can lead to misdiagnosis and inappropriate treatment.

Reported Incidents

No specific injuries or deaths have been reported related to this recall. The potential for misdiagnosis poses a high risk to patient safety.

What to Do

Stop using the recalled tests immediately. Contact Quidel Corporation or your healthcare provider for further instructions.

Contact Information

For more information, visit the FDA website or call Quidel Corporation directly for assistance. Notification letters have been sent to healthcare providers.

Key Facts

  • Recall date: June 17, 2025
  • Quantity recalled: 22,470 tests
  • Distribution: U.S. and multiple international countries
  • Potential for false positive results
  • High hazard level
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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Brand
Model Numbers
50T, REF: 20108
25T, REF: 20125
50T, SCN, REF: 20108SC
REF/UDI-DI/Lot(Expiration): 20108/30014613201083/709673(05-FEB-2026)
709676(05-FEB-2026)
+10 more
Affected States
ALL
Report Date
September 17, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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