RegWardenFDA facility compliance records
Company

Hycor Biomedical

3 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2018: 3 recalls20173201820192020202120222023202420252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2018-07-25
    Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
  • Class IIOngoing2018-03-19
    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 o…
  • Class IICompleted2018-02-21
    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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Hycor Biomedical — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-2016473-hycor-biomedical/

Not open yet

Alerts for Hycor Biomedical

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.