FDAFDA · Food and drugs·Recall number Z-2460-2026
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Published June 24, 2026 · Recall initiated: April 30, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Assayed Whole blood control contains labeling with incorrect performance range.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Accriva Diagnostics, Inc.
- Distributor
- 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.
- Lot
- Lot #: A6DLA001 Unique Device Identifier: 10711234170373
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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