- Recalling firm
- Aniara Diagnostica LLC
- Reason for recall
- Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
- Affected products (lot / model / serial)
- UDI-DI: 03663537018763; Lot Number: FD1265
- Units affected
- 359 units
- Distribution pattern
- US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
- Firm location
- West Chester, OH, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2171-2026
- Recall initiated
- April 1, 2026
- FDA classification date
- May 12, 2026
- FDA report date
- May 20, 2026
- FDA event ID
- 98754
- Last updated on HTM Vibe
- July 24, 2026