- Recalling firm
- Accriva Diagnostics, Inc.
- Reason for recall
- Assayed Whole blood control contains labeling with incorrect performance range.
- Affected products (lot / model / serial)
- Lot #: A6DLA001 Unique Device Identifier: 10711234170373
- Units affected
- 6060
- Distribution pattern
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hong Kong, Spain.
- Firm location
- San Diego, CA, United States
- Recall type
- Voluntary: Firm initiated
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2460-2026
- Recall initiated
- April 30, 2026
- FDA classification date
- June 16, 2026
- FDA report date
- June 24, 2026
- FDA event ID
- 98979
- Last updated on HTM Vibe
- July 23, 2026