FDAJuly 19, 2017device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The 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 to do
FDA enforcement status: Terminated
Brands named
kamiya biomedicalkamiya
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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