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

Reason: Assayed Whole blood control contains labeling with incorrect performance range.

Code information: Lot #: A6DLA001 Unique Device Identifier: 10711234170373

Distribution pattern: 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.