Home / Recalls / Quidel Corporation / Z-2545-2025

Z-2545-2025 Class II Ongoing

Recalled by Quidel Corporation — San Diego, CA

Recall Details

Product Type
Devices
Report Date
September 17, 2025
Initiation Date
June 17, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22470

Product Description

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

Reason for Recall

Dipstick strep A test has potential for false positive results.

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.

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)

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