Class II

Medical Device Recall: directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2

Accriva Diagnostics, Inc. · April 30, 2026

Reason for Recall

Assayed Whole blood control contains labeling with incorrect performance range.

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.

States Affected

NATIONWIDE

Quantity Affected

6060

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2460-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Accriva Diagnostics, Inc. Medical Device Recall: directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2 | SafeCheck