Facility

HYCOR BIOMEDICAL

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

Key facts

3recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000125787
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	7272 Chapman Ave GARDEN GROVE, CA, US 92841
Registration status	Active · expires 2026
Parent company	Hycor Biomedical (owner-operator 2016473)
Brand names	NOVEOS Specific IgE, Capture Reagent F075, Egg Yolk (Gallus gallus); NOVEOS Specific IgE, Capture Reagent F018, Brazil Nut (Bertholletia excelsa); NOVEOS Specific IgE, Capture Reagent F203, Pistachio Nut (Pistacia vera); NOVEOS Specific IgE, Capture Reagent F201, Pecan Nut (Carya illinoensis); NOVEOS Specific IgE, Capture Reagent F036, Coconut (Cocos nucifera); NOVEOS Specific IgE, Capture Reagent F290, Oyster (Ostrea edulis); NOVEOS Specific IgE, Capture Reagent F040, Tuna (Thunnus sp.); NOVEOS Specific IgE, Capture Reagent F041, Salmon (Salmo salar)

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (1)

System, Test, Radioallergosorbent (Rast) Immunological
Product code DHB (opens in a new tab) · Class II · Immunology · 21 CFR 866.5750

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.

FDA inspections (2)

NAI2025-11-26
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2019-05-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Hycor Biomedical

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “HYCOR BIOMEDICAL (FEI 1000125787) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000125787-hycor-biomedical/

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