FEI 1221020
Advanced Instruments, Llc
25 BRADLEY DR., WESTBROOK, ME, US
MDR events0All time
Recalls2All time
Registered products1
Establishment typeManufactureManufacture Medical Device
Registered product codes
1 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
2 on file
- Open, ClassifiedApr 29, 2024
System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when testing controls.
View FDA record ↗ - TerminatedUnknown
RBC Reagent failure. High fluorescent counts during RBC Reagent + Diluent QC check that will result in failed QC check, preventing user from testing patient samples for RBC.
View FDA record ↗
Compliance history
Matched by FEI 1221020.
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.