Devices

Device Recall KAssay

Model / Serial
Lot D407
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
The firm distributed product to 3 distributors, 1 each in CA, PA, and MN; and 2 labs, 1 each in GA and MI.
Product Description
K-Assay Lp(a) Control
Manufacturer
Kamiya Biomedical Company
1 Event
- Recall of Device Recall KAssay

Manufacturer

Kamiya Biomedical Company

Manufacturer Address
Kamiya Biomedical Company, 910 Industry Dr, Seattle WA 98188-3412
Source
USFDA

One device with a similar name

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Device Recall KAssay(R) MultiAnalyte Calibrator

Model / Serial
Lot Numbers: N653, N654, D755, D647, F648, F649, G650, J651, L652
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
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
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
Manufacturer
Kamiya Biomedical Company, LLC

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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