FDA-Device2026-06-24Class IIMISBRANDING
Accriva Diagnostics directCHECK ACT-LR quality control recalled for incorrect labeling
What this means
Accriva Diagnostics' directCHECK ACT-LR whole blood quality control product (level 2, lot A6DLA001) has incorrect performance range information on its label. This labeling error could lead to misinterpretation of test results if the correct reference range is not known.
- Check if your laboratory uses directCHECK ACT-LR level 2 from lot A6DLA001
- Contact Accriva Diagnostics or your supplier for corrected labeling or instructions
- Do not use the product until you have confirmed the correct performance range with the manufacturer
The agency's original wording
Hazard
Assayed Whole blood control contains labeling with incorrect performance range.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
6060
Manufactured in
6260 Sequence Dr, San Diego, CA, United States
Products
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2460-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.