Helena Laboratories, Corp. recalls

11 recalls on record · latest: May 2, 2023

Official U.S. recall history for Helena Laboratories, Corp., compiled from official government records.

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Helena Laboratories, Corp. recalls Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applica…

May 2, 2023 · Medical device recalls Moderate risk Packaging for a serrated blade applicator kit (12 Sample) may contain a serrate…

Helena Laboratories, Corp. recalls V8 Immunodisplacement Kit REF 1803

April 6, 2022 · Medical device recalls Moderate risk Due to microbial growth causing interference with interpretation.

Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the…

January 5, 2021 · Medical device recalls Moderate risk Intermittent potential for shorter than expected clot times.

Helena Laboratories, Corp. recalls K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MIN…

November 9, 2020 · Medical device recalls Moderate risk Due to complaints received associated with cracked/split test tube caps.

Helena Laboratories, Corp. recalls ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena L…

August 8, 2018 · Medical device recalls Moderate risk The positive control on some tests of the lots did not appropriately react with…

Helena Laboratories, Corp. recalls ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena…

August 8, 2018 · Medical device recalls Moderate risk The positive control on some tests of the lots did not appropriately react with…

Helena Laboratories, Corp. recalls Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containin…

May 23, 2018 · Medical device recalls Through an investigation, it has been determined that vials of Collagen package…

Helena Laboratories, Corp. recalls Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon)…

May 23, 2018 · Medical device recalls Through an investigation, it has been determined that vials of Collagen package…

Helena Laboratories, Corp. recalls SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose elec…

February 27, 2018 · Medical device recalls Lots of gel kits contained a newer revision of the Customer Procedures instruct…

Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont…

December 7, 2017 · Medical device recalls Moderate risk Some of the cards show occasional shorter clot times than the expected variatio…

Helena Laboratories, Corp. recalls SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laborato…

July 21, 2017 · Medical device recalls Moderate risk The plates do not have wells punched for the controls in the patient 1 area.