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Recall Observatory FDA recall evidence

Device product

QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC

Z-2545-2025

June 17, 2025

Class II

Product summary

Firm
Quidel Corporation
Event
Event 97271
Status
Ongoing
Classification
Class II
Quantity
22470
Official record key
device-enforcement:Z-2545-2025

Official wording

Reason: Dipstick strep A test has potential for false positive results.

Code information: 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 pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Dipstick strep A test has potential for false positive results.