Kamiya Biomedical Company, LLC recalls K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-An…

Recall date

July 19, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3138-2017

FDA classification

Class II

Brand / firm

Kamiya Biomedical Company, LLC

Sold / distributed

Worldwide Distribution - US including FL, CA, WA, OH, IA, IL, NJ, NY, NC, MA, TX, CT, MD, VA, Internationally to TN, Czech Republic, Taiwan, Dominican Republic, Switzerland, China, and Jamaica

Why it was recalled

The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use