- Recalling firm
- Quidel Corporation
- Reason for recall
- Product has the potential for false positive results
- Affected products (lot / model / serial)
- UDI/DI 30014613201083, Lot Numbers: 225788, 228322, 233274.
- Units affected
- 12279 units
- 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.
- Firm location
- San Diego, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2169-2026
- Recall initiated
- April 6, 2026
- FDA classification date
- May 12, 2026
- FDA report date
- May 20, 2026
- FDA event ID
- 98709
- Last updated on HTM Vibe
- July 24, 2026