Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
K-Assay(R) Multi-Analyte Calibrator Recalled by Kamiya Biomedical Company, LLC Due to The AlAT calibrator values in the package insert...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Kamiya Biomedical Company, LLC directly.
Affected Products
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
Quantity: 1398 units
Why Was This Recalled?
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
Where Was This Sold?
This product was distributed to 15 states: CA, CT, FL, IL, IA, MD, MA, NJ, NY, NC, OH, TN, TX, VA, WA
About Kamiya Biomedical Company, LLC
Kamiya Biomedical Company, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report