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
Reported: September 27, 2017 Initiated: July 19, 2017 #Z-3138-2017
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.
Details
- Recalling Firm
- Kamiya Biomedical Company, LLC
- Units Affected
- 1398 units
- Distribution
- 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
- Location
- Tukwila, WA
Frequently Asked Questions
What product 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. Recalled by Kamiya Biomedical Company, LLC. Units affected: 1398 units.
Why was this product recalled? ▼
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 27, 2017. Severity: Moderate. Recall number: Z-3138-2017.
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