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Helena Laboratories, Corp.

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
282
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1975-2023Class IISerrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, ContentMay 2, 2023
Z-1244-2022Class IIV8 Immunodisplacement Kit REF 1803April 6, 2022
Z-1108-2021Class IICascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and aJanuary 5, 2021
Z-0635-2021Class IIK-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZENovember 9, 2020
Z-1949-2019Class IIColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on August 8, 2018
Z-1950-2019Class IIColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on tAugust 8, 2018
Z-0536-2020Class IIIPlatelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADMay 23, 2018
Z-0537-2020Class IIICollagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: CollagMay 23, 2018
Z-0297-2020Class IIISPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoFebruary 27, 2018
Z-2761-2019Class IICascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena LaDecember 7, 2017
Z-0045-2020Class IISPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the labeJuly 21, 2017
Z-0106-2019Class II"Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total ProApril 4, 2017
Z-0561-2019Class IICascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORAFebruary 24, 2017
Z-0529-2019Class IIIGel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. NNovember 7, 2016
Z-2434-2019Class IITitan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mLOctober 14, 2016
Z-0594-2019Class IICascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORAApril 20, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K213396SPIFE A1AT kitOctober 13, 2022
K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlApril 19, 2022
K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLOctober 7, 2013
K100103SPECIALTY ASSAYED CONTROL-2December 15, 2010
K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAFebruary 23, 2007
K061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALEJuly 6, 2006
K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPMay 10, 2006
K050053HEMORAM/AGGRAM ANALYZERJuly 11, 2005
K024162SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389February 19, 2003
K023761PLATELETWORKS, MODELS PW-A, PW-CFebruary 14, 2003
K022757SPIFE CK KIT, MODEL 3332, 3333October 11, 2002
K022455SPIFE LD-12 KIT, MODEL 3338October 1, 2002
K022333SPIFE LIPPOROTEIN-12, MODEL 3344August 15, 2002
K020914ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770May 23, 2002
K020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346May 6, 2002
K020467SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452March 29, 2002
K013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752January 10, 2002
K013466SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343December 21, 2001
K012723PLATELETWORKSSeptember 28, 2001
K010617SPIFE IFE CALIBRATOR AND CONTROL KITMarch 15, 2001