Remel, Inc.
12076 Santa Fe Trail Dr, LENEXA, KS, US
Registered product codes
74 product codes
Recent MDR events
38 on file
- REMELJan 26, 2026Malfunction24176882
- REMEL CHOCOLATE AGAR MEDIAOct 27, 2025InjuryMW5177970
- REMEL CHOCOLATE AGAR MEDIAOct 27, 2025InjuryMW5177971
- REMEL CHOCOLATE AGAR MEDIAOct 27, 2025InjuryMW5177972
- REMEL CHOCOLATE AGAR MEDIAOct 27, 2025InjuryMW5177973
- REMEL CHOCOLATE AGAR MEDIAOct 27, 2025InjuryMW5177974
- TRYPTICASE SOY BROTHMar 4, 2025MalfunctionMW5167166
- TRYPTICASE SOY BROTHMar 4, 2025MalfunctionMW5167167
- TRYPTICASE SOY BROTHMar 4, 2025MalfunctionMW5167168
- TRYPTICASE SOY BROTHMar 4, 2025MalfunctionMW5167169
Recalls
113 on file
- Open, ClassifiedJun 30, 2026
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
View FDA record ↗ - Open, ClassifiedApr 10, 2026
Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
View FDA record ↗ - Open, ClassifiedFeb 26, 2026
Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
View FDA record ↗ - Open, ClassifiedNov 21, 2025
Products may contain contamination, which may result in a darker or brown media color.
View FDA record ↗ - Open, ClassifiedJul 31, 2025
The products may contain surface and subsurface contamination of Listeria monocytogenes.
View FDA record ↗ - Open, ClassifiedJul 31, 2025
The products may contain surface and subsurface contamination of Listeria monocytogenes.
View FDA record ↗ - Open, ClassifiedJul 31, 2025
The products may contain surface and subsurface contamination of Listeria monocytogenes.
View FDA record ↗ - Open, ClassifiedJul 31, 2025
The products may contain surface and subsurface contamination of Listeria monocytogenes.
View FDA record ↗ - Open, ClassifiedJun 11, 2025
Product may have an off color affecting perfomance
View FDA record ↗ - Open, ClassifiedMar 19, 2025
Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
View FDA record ↗
Compliance history
Matched by FEI 1924669.
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.