- Recalling firm
- Abbott Diagnostics Scarborough, Inc.
- Reason for recall
- It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Affected products (lot / model / serial)
- List Number: 427-000; UDI-DI: 10811877010422; Lot Number: 000X133126; Expiry: 2027 02 21;
- Units affected
- 111984 units
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Scarborough, ME, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1565-2026
- Recall initiated
- February 9, 2026
- FDA classification date
- March 13, 2026
- FDA report date
- March 25, 2026
- FDA event ID
- 98400
- Last updated on HTM Vibe
- July 24, 2026