Z-2545-2025 Class II Ongoing
FDA device recall Z-2545-2025 was initiated by Quidel Corporation on June 17, 2025 and is designated Class II. Reason for recall: Dipstick strep A test has potential for false positive results. The recall status is ongoing. Affected quantity: 22470.
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)