FEI 2244894
Emd Millipore Corporation
400 Summit Drive, Burlington, MA, US
MDR events1All time
Recalls2All time
Registered products31
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
31 product codes
Recent MDR events
1 on file
Recalls
2 on file
- Open, ClassifiedFeb 23, 2024
This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
View FDA record ↗ - Open, ClassifiedNov 29, 2023
Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles.
View FDA record ↗
Compliance history
Matched by FEI 2244894.
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.