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
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. 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.