Kamiya Biomedical Company Llc
12779 Gateway Dr S, Tukwila, WA, US
Registered product codes
33 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
4 on file
- Open, ClassifiedNov 21, 2022
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
View FDA record ↗ - TerminatedJan 19, 2011
Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.
View FDA record ↗ - TerminatedMar 4, 2010
The long-term stability of level 2 (1.0 mg/dL) may not be within the specifications due to a decrease in CRP concentration.
View FDA record ↗ - TerminatedUnknown
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
View FDA record ↗
Compliance history
Matched by FEI 2084025.
FDA inspections
2 on file
- No Action Indicated (NAI)May 16, 2024
Compliance: Devices
- No Action Indicated (NAI)May 16, 2024
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.