Z-2169-2026 Class II Ongoing
FDA device recall Z-2169-2026 was initiated by Quidel Corporation on April 6, 2026 and is designated Class II. Reason for recall: Product has the potential for false positive results The recall status is ongoing. Affected quantity: 12279 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- April 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12279 units
Product Description
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
Reason for Recall
Product has the potential for false positive results
Distribution Pattern
US Nationwide distribution in the states of AL, CA, FL, ID, IL, LA, MA, MD, MN, MO, NY, PA, SC, TN, TX, VA.
Code Information
UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.