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HYCOR BIOMEDICAL LLC

United States·US-MF-000031449

Last updated September 17, 2026

Information

Page 10 of 10

Device	Model / Reference	Registries	Class	Status
Ventrex Allergen Disc	K924044	FDA 510(k)	Class II	Active
Hytec Autoimmune Kit (ss-A)	K954392	FDA 510(k)	Class II	Active
Hycor Sentry Drugs Of Abuse Urine Control:	K890957	FDA 510(k)	Class I	Active
Hy*tec Extended Specific Ige Eia, Mcs Assay Using Tecan Freedom Evo Rsp 200	K080322	FDA 510(k)	Class II	Active
Hycor Accupinch Phencyclidine Test	K900921	FDA 510(k)	U	Active
NOVEOS flex Immunoassay System	FX64000	EUDAMED	Class A	Active
Accuracy and Precision Kit	530005	EUDAMED	Class A	Active
Sample Dilution Cups	123322-20	EUDAMED	Class A	Active
Cuvette Wash Solution	63190	EUDAMEDFDA UDI	Class A	Active
Substrate Mix Container	118877-001	EUDAMEDFDA UDI	Class A	Active
Probe Wash Solution	63170	EUDAMEDFDA UDI	Class A	Active
Substrate Mix Container Pack	FX64006	EUDAMED	Class A	Active
Cuvette Pack	FX64007	EUDAMED	Class A	Active
Anti-evaporation Caps	FX64009	EUDAMED	Class A	Active
Cuvette Arcs	117450-001	EUDAMEDFDA UDI	Class A	Active
Caps for 5 mL Tubes	137533-100	EUDAMED	Class A	Active
Wash Buffer	63165	EUDAMEDFDA UDI	Class A	Active
Optics Tips	119844-001	EUDAMEDFDA UDI	Class A	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 25, 2018	Z-0224-2020	—	open, classified	Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
Mar 19, 2018	Z-2200-2019	—	open, classified	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.
Feb 21, 2018	Z-2134-2019	—	completed	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.