Reported Sep 27, 2017 · Terminated
K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R)…
Kamiya Biomedical Company, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kamiya Biomedical Company, LLC · 12779 Gateway Dr S · Tukwila, WA · 98168-3308
Is this the product you have?
- 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
- Lot codes and dates
- Lot Numbers
N653N654D755D647F648F649G650J651L652
- Lot Numbers
- Amount recalled
- 1398 units
Where it was sold
Why it was recalled
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
This product could cause temporary or reversible health problems — stop using it.
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