Quidel recalls 22,470 Rapid Strep A Dipstick tests sold worldwide, including multiple U.S. states. The dipstick test may yield false positive results. Health providers and patients should stop using the device immediately and follow recall instructions. Check with Quidel for refund or replacement options.
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
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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.
False positives can lead to unnecessary treatment, misdiagnosis, and misguided clinical decisions. This recall covers multiple lots with potential false positives.
This recall is not part of a broader industry pattern.
Clinicians may perform unnecessary treatments or follow-up actions based on false positive results; patients may experience anxiety or unnecessary antibiotic exposure.
FDA recall page and Quidel recall communications; lot numbers and expiration dates on packaging
Refunds or replacements are processed per recall instructions; typical timelines range weeks
Keep recall notice, packaging photos, receipts, correspondence, and lot numbers
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.
No specific injuries or incidents are described in the provided data.
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