FDAHealthApril 30, 2026

Accriva Diagnostics, Inc. — directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

⚠️ Assayed Whole blood control contains labeling with incorrect performance range.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: April 30, 2026

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.

What's affected?

Product: directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Brand: Accriva Diagnostics, Inc.
Lot code: A6DLA001

Additional details

Lot #: A6DLA001 Unique Device Identifier: 10711234170373

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 6060.

View original FDA notice →

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