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

Hazard

Assayed Whole blood control contains labeling with incorrect performance range.

Details from the source

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. Quantity: 6060 Lot/code info: Lot #: A6DLA001 Unique Device Identifier: 10711234170373

UPC codes

10711234170373

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.