Kamiya Biomedical Company, LLC: Medical Device Recall in 2017 - (Recall #: Z-3138-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 19, 2017

Date Posted: September 27, 2017

Recall Number: Z-3138-2017

Event ID: 77916

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.

Status: Terminated

Product Quantity: 1398 units

Code Information:

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

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

Voluntary or Mandated:

Voluntary: Firm initiated