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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 3 of 14

Device	Model / Reference	Registries	Class	Status
Actalyke XL, (CSA/CE), W/ Flash Memory	5770004	FDA UDI	Class II	Active
CK/LD Isoenzyme Control (5 x 2 mL)	5134	FDA UDI	Class I	Active
Titan III-H Cellulose Acetate Plate	3022	FDA UDI	Class II	Active
SPIFE Ultra ImmunoFix-6 Gel Kit	552578	FDA UDI	Class II	Active
QuickScan Touch, Export Version 2, V800	1692001	FDA UDI	Class I	Active
ESH Touch (120/230V)	1380000	FDA UDI	Class I	Active
QuickScan 2000 Software, Version 2.02	1678000	FDA UDI	Class I	Active
SPIFE ImmunoFix-9 Urine Accessory Kit	552391	FDA UDI	Class II	Active
SPIFE Acid Hemoglobin Kit	552606	FDA UDI	Class II	Active
QUICKGEL Lipoprotein Gel Kit	552363	FDA UDI	Class I	Active
Super Z 12-Applicator (12-sample)	4090	FDA UDI	Class I	Active
SPIFE LD Reagent Kit	500610	FDA UDI	Class II	Active
ColoScreen	551565	FDA UDI	Class II	Active
Lyophilized Platelets	5356	FDA UDI	Class II	Active
ColoCARE Office Pack	5651	FDA UDI	Class II	Active
SPIFE IgG IEF-20 Kit	3385	FDA UDI	Class II	Active
ProtoFluor Calibrator - Low (5 x 2.5 mL)	2010	FDA UDI	Class I	Active
SPIFE 4000 White Sample Tray	2315	FDA UDI	Class I	Active
Blade Applicator Kit, 18 Sample	552594	FDA UDI	Class II	Active
SPIFE Nexus Acid Hemoglobin Kit	552734	FDA UDI	Class II	Active
von Willebrand Factor Antigen ELISA Kit (96 tests)	5290	FDA UDI	Class II	Active
SPIFE Nexus Dispo Stain Cups	2575000	FDA UDI	Class I	Active
SPIFE Ultra ImmunoFix-9 Gel Kit	552579	FDA UDI	Class II	Active
ProtoFluor Reagent (2x15 mL)	2002	FDA UDI	Class I	Active
SPIFE Alkaline Phosphatase Reagent Kit	552055	FDA UDI	Class II	Active
SPIFE Touch, CSA 2015 (120V)	1068001	FDA UDI	Class I	Active
TITAN GEL Alkaline Phosphatase Kit	3058	FDA UDI	Class II	Active
Helena Ristocetin - 10 mg/mL	5372	FDA UDI	Class II	Active
Antiserum to Human IgM	9234	FDA UDI	Class II	Active
ImmunoFix Controls	9400	FDA UDI	Class II	Active
QuickGel IFE Gel Kit	552307	FDA UDI	Class II	Active
Neutral Density Densitometer Control for QuickScan	1031000	FDA UDI	Class I	Active
SPIFE Split Beta 80, 100 Bulk Kit	552581	FDA UDI	Class I	Active
Hi Res Protein Marker	5141	FDA UDI	Class I	Active
V8 Waste Drawer Pack	1820	FDA UDI	Class II	Active
QuickScan Touch, Export Version 2	1692000	FDA UDI	Class I	Active
Alkaline Phosphatase Isoenzyme Control (1 x 1 mL)	5139	FDA UDI	Class I	Active
Quickgel Modified Applicator Blades And Deep Well Cups	552136	FDA UDI	Class I	Active
QuickScan 2000 (Windows 2000) Software and Computer, Version 2.01	1679000	FDA UDI	Class I	Active
Factor X Deficient Substrate Plasma	5195	FDA UDI	Class II	Active
Double Diffusion Plates (10/pkg)	9009	FDA UDI	Class I	Active
Fibrinogen Assay Kit	5376	FDA UDI	Class II	Active
SPIFE Urine IFE-6 Accessories	3390	FDA UDI	Class I	Active
SPIFE Nexus IFE-6 Gel Kit	552694	FDA UDI	Class II	Active
Citrate Buffer	5121	FDA UDI	Class II	Active
G-ACT Tubes	G-ACT	FDA UDI	Class II	Active
Actalyke MAX-ACT Tubes	MAX-ACT	FDA UDI	Class II	Active
SPIFE Nexus Split Beta SPE -20, 40, 60 Gel Kit	552692	FDA UDI	Class I	Active
SPIFE 4000 Maintenance Blotters	2307	FDA UDI	Class I	Active
H-Pette without Blade (1000 pieces)	3611	FDA UDI	Class I	Active

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Authorities

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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