FEI 3002806809
Sekisui Diagnostics P.e.i. Inc.
70 Watts Avenue, CHARLOTTETOWN Prince Edward Island, CA
MDR events0All time
Recalls2All time
Registered products47
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
47 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
2 on file
- TerminatedJan 23, 2017
Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
View FDA record ↗ - TerminatedUnknown
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover
View FDA record ↗
Compliance history
Matched by FEI 3002806809.
FDA inspections
0 on file
No inspections on file for this FEI number.
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.