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
Hazard
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
What You Should Do
Remedy
Kamiya Biomedical Company sent an Urgent Medical Device Recall/Correction Notice on July 14, 2017 to affected customers, providing them with updated package inserts with corrected A1AT values and/or free replacement kits. Customers were asked to fill in and return the acknowledgement form. Customers with questions were instructed to contact the firm at 206-575-8068.
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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) Alp
- Brand
- Kamiya Biomedical Company, LLC
- UPC
- Lot Numbers: N653, N654, D755, D647, F648, F649, G650, J651, L652
Units Affected
1398 units