← FDA ENFORCEMENT
Z-2460-2026Class II
Accriva Diagnostics, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Accriva Diagnostics, Inc.
Product type
Device
Status
Ongoing
Report date
2026-06-24
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.
Firm state
CA
Product quantity
6060
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Assayed Whole blood control contains labeling with incorrect performance range.
Product description
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Code / lot info
Lot #: A6DLA001 Unique Device Identifier: 10711234170373
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →