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Helena Laboratories, Corp.

Last updated September 17, 2026

About

Helena Laboratories provides quality products and services to customers worldwide. Our products include electrophoresis analyzers and supplies, densitometers, hemostasis reagents and instruments, immunology and protein diagnostic systems, disposable laboratory plasticware, fecal occult blood test kits, and a wide range of additional laboratory solutions.

From the manufacturer's own website. Source

Information

Country: US
Address: 1530 Lindbergh Dr, BEAUMONT, TX, 77707
Website: www.helena.com
LinkedIn: linkedin.com/company/helena-laboratories-corporation
Facebook: facebook.com/HelenaLaboratories
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1618982
DUNS Number: —

Catalogue (662)

Page 5 of 14

Device	Model / Reference	Registries	Class	Status
SPE Control (1 x 2 mL)	5136	FDA UDI	Class I	Active
IFE Free Lambda Light Chain Antiserum	9423	FDA UDI	Class II	Active
Titan Gel Immunofix-Plus Kit	3067	FDA UDI	Class II	Active
Spife Ultra Ife-6 Antisera Kit	552289	FDA UDI	Class II	Active
QuickGel IFE Applicator Blades and Sample Cups	552472	FDA UDI	Class II	Active
Ristocetin Cofactor Abnormal Control Plasma	5373	FDA UDI	Class II	Active
Protein S ELISA Kit	5292	FDA UDI	Class II	Active
IFE IgE Antiserum	9410	FDA UDI	Class II	Active
ColoScreen III 1000 Slide Pack	5083	FDA UDI	Class II	Active
ColoCare - 9 Health Fair	552138	FDA UDI	Class II	Active
QuickGel Disposable Sample Cups - Shallow Well	1269	FDA UDI	Class I	Active
Titan III-H Cellulose Acetate Plate	3021	FDA UDI	Class II	Active
TITAN GEL Chamber Cooling Block	3039	FDA UDI	Class I	Active
Monoclonal Free Protein S ELISA Kit	5293	FDA UDI	Class II	Active
SPIFE CK-20, 40 Gel Kit	552015	FDA UDI	Class II	Active
SPIFE Vis Cholesterol Kit	552614	FDA UDI	Class I	Active
Electra B1 Buffer	5016	FDA UDI	Class I	Active
QuickScan (Windows 2000) Software, Version 2.02, and Key	1673001	FDA UDI	Class I	Active
Normal Human Serum Control	9010	FDA UDI	Class II	Active
Factor V Deficient Substrate Plasma	5191	FDA UDI	Class II	Active
SPIFE 4000, Windows 7 (220V)	1621003	FDA UDI	Class I	Active
Helena Electronic Clotting Tube	XL-ECT1	FDA UDI	Class I	Active
QuickScan Touch	1690000	FDA UDI	Class I	Active
SPIFE Nexus IFE-6 Antisera Kit	552703	FDA UDI	Class II	Active
von Willebrand Factor Antigen Rocket Kit	5361	FDA UDI	Class II	Active
Hemolysate Reagent	5128	FDA UDI	Class II	Active
NORM-TROL 1 Coagulation Control	5186	FDA UDI	Class II	Active
Epinephrine Reagent	5367	FDA UDI	Class II	Active
SPIFE 4000 Blue Sample Tray	2316	FDA UDI	Class I	Active
Actalyke Mini II, w/ Printer, w/o Battery, "CE 2009" (110V/220V)	5753001	FDA UDI	Class II	Active
AA2 Hemo Control	5328	FDA UDI	Class II	Active
SPIFE Urine IFE-9 Accessories (50 templates & blotters)	3391	FDA UDI	Class I	Active
SPIFE IgG IEF Kit, Part 2	552089	FDA UDI	Class II	Active
Actalyke XL, Dual Detection, (Display #2) "CE" (110V/220V)	5770002	FDA UDI	Class II	Active
QuickScan 2000 Windows Software & Key	1673000	FDA UDI	Class I	Active
SPIFE Vis Cholesterol Reagent Kit	551941	FDA UDI	Class I	Active
Normal HbA2 Quik Column Control	5339	FDA UDI	Class II	Unknown
Antiserum to Human IgA	9231	FDA UDI	Class II	Active
SPE Abnormal Control (10 x 2 mL)	3425	FDA UDI	Class I	Active
Titan III Cellulose Acetate (94 x 76 mm)	3024	FDA UDI	Class I	Active
QuickGel Applicator	1265000	FDA UDI	Class I	Active
QuickGel IFE Antisera Kit	552454	FDA UDI	Class II	Active
APTT-SA (Soluble Activator) Reagent Kit	5387	FDA UDI	Class II	Active
Albumin Marker	9011	FDA UDI	Class II	Active
V8 Immunodisplacement Kit	1803	FDA UDI	Class II	Active
SPIFE ImmunFix-15 Urine Accessory Kit	552392	FDA UDI	Class II	Active
SPIFE Ultra ImmunoFix-9 Antisera Kit	552164	FDA UDI	Class II	Active
SPIFE LD Gel Kit	552610	FDA UDI	Class II	Active
Lipoprotein Stain (1 x 2.8 g Powder)	5322	FDA UDI	Class I	Active
SPIFE ALP Separation Enhancer	3348	FDA UDI	Class II	Active

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FDA Recalls (16)

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
May 2, 2023	Z-1975-2023	—	open, classified	Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result.
Apr 6, 2022	Z-1244-2022	—	open, classified	Due to microbial growth causing interference with interpretation.
Jan 5, 2021	Z-1108-2021	—	terminated	Intermittent potential for shorter than expected clot times.
Nov 9, 2020	Z-0635-2021	—	open, classified	Due to complaints received associated with cracked/split test tube caps.
Aug 8, 2018	Z-1950-2019	—	open, classified	The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
Aug 8, 2018	Z-1949-2019	—	open, classified	The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.
May 23, 2018	Z-0536-2020	—	open, classified	Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.
May 23, 2018	Z-0537-2020	—	open, classified	Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.
Feb 27, 2018	Z-0297-2020	—	open, classified	Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users.
Dec 7, 2017	Z-2761-2019	—	terminated	Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Jul 21, 2017	Z-0045-2020	—	terminated	The plates do not have wells punched for the controls in the patient 1 area.
Apr 4, 2017	Z-0106-2019	—	terminated	Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate.
Feb 24, 2017	Z-0561-2019	—	terminated	Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
Nov 7, 2016	Z-0529-2019	—	terminated	Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted.
Oct 14, 2016	Z-2434-2019	—	terminated	Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range.
Apr 20, 2016	Z-0594-2019	—	terminated	Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected