Dipstick strep A tests recalled over potential for false positive results
QuickVue Dipstick Strep A Tests are recalled because the test has the potential for false positive results. 22,470 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; false positive results could lead to unnecessary treatment and no injuries are reported.
Plain-English summary
The QuickVue Dipstick Strep A Test is being recalled in the 50-test REF 20108, 25-test REF 20125 and 50-test SCN REF 20108SC presentations. Affected lots include 709673 and 709676 expiring 05-FEB-2026 and 709484 expiring 09-JAN-2026, with the full list in the recall notice. The recall covers 22,470 units distributed across many states and internationally.
The recall was issued because the dipstick strep A test has the potential for false positive results. The FDA classified the action as Class II.
Laboratories and clinics holding affected lots should follow the manufacturer's instructions on affected stock and on results already reported.
The recalled product
- Product
- QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
- Manufacturer
- Quidel Corporation
- Affected units
- 22,470
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
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