Home / Recalls / Kamiya Biomedical Company, LLC / Z-3138-2017

Z-3138-2017 Class II Terminated

Recalled by Kamiya Biomedical Company, LLC — Tukwila, WA

Recall Details

Product Type: Devices
Report Date: September 27, 2017
Initiation Date: July 19, 2017
Termination Date: November 20, 2018
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1398 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot Numbers: N653, N654, D755, D647, F648, F649, G650, J651, L652