QuickVue Dipstick Strep A Test Recalled for False Positive Results
Quidel Corporation is recalling the QuickVue Dipstick Strep A Test (50T, REF 20108) due to the potential for false positive results. The product was distributed nationwide.
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: This is an FDA Class II recall involving a diagnostic device with potential for false positive results, which could lead to incorrect medical diagnosis and treatment. Although no illnesses or injuries are reported in the source text, the risk of diagnostic error affecting patient care justifies a High severity rating.
Plain-English summary
Quidel Corporation is recalling QuickVue Dipstick Strep A Test, 50T, REF 20108 (UDI/DI 30014613201083), because the product has the potential for false positive results. The affected lot numbers are 225788, 228322, and 233274. A total of 12,279 units were distributed nationwide to the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, and VA.
False positive results may lead to incorrect diagnosis and inappropriate treatment decisions for patients tested with the affected product. Healthcare providers and patients who have used this product should be aware of this issue.
Consumers and healthcare facilities should stop using the affected lot numbers immediately and contact Quidel Corporation for guidance on product replacement or disposal. Patients who may have received a positive test result from affected lots should consult their healthcare provider to verify the accuracy of their diagnosis.
The recalled product
- Product
- QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
- Manufacturer
- Quidel Corporation
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-positive-results
- diagnostic-error
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 (4)
- UDI/DI 30014613201083
- Lot Numbers: 225788
- 228322
- 233274.
Distribution
Distributed nationwide across the United States.