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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 7 of 14

Device	Model / Reference	Registries	Class	Status
Titan III Cellulose Acetate Carrying Rack (1/pkg)	5110	FDA UDI	Class I	Active
SPIFE Dispo Sample Cups - Shallow Well	3369	FDA UDI	Class I	Active
Spife 3000, "ce 2011" (120v)	1088002	FDA UDI	Class I	Active
V8 Urine Preparation Buffer	1836	FDA UDI	Class I	Active
SPIFE Touch (230V)	1069000	FDA UDI	Class I	Active
SPIFE Dispo Sample Cups - Deep Well	552168	FDA UDI	Class I	Active
SPIFE Urine/CSF Protein Accessories (50 templates plus blotters)	3427	FDA UDI	Class I	Active
ColoCARE Hospital Pack	5656	FDA UDI	Class II	Active
Blade Applicator Kit, 20 Sample	552590	FDA UDI	Class II	Active
IFE Free Lambda Light Chain Antiserum	9413	FDA UDI	Class II	Active
Plateletworks Collagen Kit	5862	FDA UDI	Class II	Active
0.25 M Calcium Chloride	5386	FDA UDI	Class II	Active
SPIFE 4000, Windows 7 (110V)	1620003	FDA UDI	Class I	Active
Actalyke Mini II, w/o Printer & Battery., "CE" (110V/220V)	5755000	FDA UDI	Class II	Active
QuickGel IFE Applicator Blades	1272	FDA UDI	Class I	Active
QuickGel Split Beta SPE 10/20 Gel Kit	552297	FDA UDI	Class I	Active
SPIFE Nexus Alkaline Hemoglobin Gel Kit	552733	FDA UDI	Class II	Active
ColoScreen III Office Pack	5071	FDA UDI	Class II	Active
TITAN GEL High Resolution Protein Kit	3040	FDA UDI	Class I	Active
Bufferizer	5093	FDA UDI	Class I	Active
Rocket Stain	5360	FDA UDI	Class II	Active
SPIFE Acid Hemoglobin Kit	551951	FDA UDI	Class II	Active
ProtoFluor Calibrator - High (5 x 2.5 mL)	2011	FDA UDI	Class I	Active
ESH, "CE", (New Pump)	1341001	FDA UDI	Class I	Active
QuickGel Acid Hemoglobin 10/20 Gel Kit	552007	FDA UDI	Class II	Active
QuickGel Alkaline Hemoglobin Gel Kit	552110	FDA UDI	Class II	Active
QucikGel Applicator Blades	1270	FDA UDI	Class I	Active
Thrombin Clotting Time Reagent	5377	FDA UDI	Class II	Active
TITAN GEL IFE Antiserum Trivalent (G, A, M)	9411	FDA UDI	Class II	Active
Super Z-12 Applicator Kit (12-sample)	4093	FDA UDI	Class I	Active
ESH, "CE", (New Computer)	1341002	FDA UDI	Class I	Active
SPIFE ImmunoFix-9/15 Applicator Kit	551850	FDA UDI	Class II	Active
Plateletworks Combo-10 Kit	5854	FDA UDI	Class II	Active
Protein C ELISA Kit	5291	FDA UDI	Class II	Active
Owren's Veronal Buffer	5375	FDA UDI	Class II	Active
AggRAM Module (Domestic)	8JF52001	FDA UDI	Class II	Active
SPIFE 4000 Alkaline Hemoglobin Gel Kit	2320	FDA UDI	Class II	Active
SPIFE Disposable Sample Cups - Deep Well	3360	FDA UDI	Class I	Active
Cascade M/M-4 Cuvettes	1718	FDA UDI	Class I	Active
QuickGel Modified Applicator Blades	1271	FDA UDI	Class I	Active
QuickGel Accessory Kit	3426	FDA UDI	Class II	Active
Blade Applicator Kit, 18 Sample	552596	FDA UDI	Class II	Active
QuickGel Disposable IFE Sample Cup Strips	1258	FDA UDI	Class II	Active
IFE Free Kappa Light Chain Antiserum	9422	FDA UDI	Class II	Active
Titan III Cellulose Acetate (76 x 76 mm)	3033	FDA UDI	Class I	Active
Zip Zone Sponge Wicks	9014	FDA UDI	Class I	Active
AggRAM Analyzer (110V/220V)	1484001	FDA UDI	Class II	Active
SPIFE 3000 w/ New Pump & Valve (220V)	1089001	FDA UDI	Class I	Active
SPIFE LD Gel Kit	552012	FDA UDI	Class II	Active
ColoScreen Triples 1000 Pack w/o Developer	552052	FDA UDI	Class II	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