FDAFDA recall Z-2460-2026 · Jun 24, 2026
Accriva Diagnostics, Inc.: directCHECK ACT-LR whole blood quality control recall
Recall found
Product
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Reason for recall
Assayed Whole blood control contains labeling with incorrect performance range.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot #: A6DLA001 Unique Device Identifier: 10711234170373
- Quantity
- 6060
- Distribution
- 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.
- Recalling firm
- Accriva Diagnostics, Inc., San Diego, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-04-30
Source: openFDA enforcement record Z-2460-2026 · search recall number Z-2460-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.