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.
Dipstick strep A test has potential for false positive results.
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
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 Dipstick Strep A Test may yield false positive results. This risk can lead to misdiagnosis and inappropriate treatment.
No specific injuries or deaths have been reported related to this recall. The potential for misdiagnosis poses a high risk to patient safety.
Stop using the recalled tests immediately. Contact Quidel Corporation or your healthcare provider for further instructions.
For more information, visit the FDA website or call Quidel Corporation directly for assistance. Notification letters have been sent to healthcare providers.
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