United StatesdirectCHECK ACT-LR whole blood quality control, level 2 (Model/Catalog DCGLR-2, Lot A6DLA001, UDI 10711234170373) distributed worldwide — including the United States (nationwide) and Canada, Hong Kong and Spain — is being recalled. The product was recalled because the assayed whole blood control contains labeling with an incorrect performance range.
What's being recalled
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Recalling firm: Accriva Diagnostics, Inc., San Diego, CA, United States.
How to identify it
Lot #: A6DLA001 Unique Device Identifier: 10711234170373
The hazard
Assayed Whole blood control contains labeling with incorrect performance range.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada