Hycor Biomedical
7272 Chapman Ave, GARDEN GROVE, CA, US
Registered product codes
4 product codes
Recent MDR events
4 on file
Recalls
3 on file
- Open, ClassifiedUnknown
Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
View FDA record ↗ - CompletedUnknown
Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor.
View FDA record ↗ - Open, ClassifiedUnknown
Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.
View FDA record ↗
Compliance history
Matched by FEI 1000125787.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 26, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Nov 26, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.100(b)Nov 26, 2025
Documentation
- 21 CFR 820.198(b)Nov 26, 2025
Rationale documented for no investigation
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.