Safety Alert: Class II: Dipstick strep A test has potential for false positive results.
healthClass IIRecalled on Sep 17, 2025
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
🔢 22470
Sold At: Quidel Corporation(Worldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC, FL, TN, MS, MN, IL, MO, KS, LA, TX, CO, ID, CA, AK, NY, PA and the countries of Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, Turkey.)
Recall #: FDA-DEVICE-Z-2545-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- 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)
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Summary
Dipstick strep A test has potential for false positive results.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Quidel Corporation for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.