Helena Laboratories, Corp.
Beaumont, TX
This page shows every FDA and USDA recall linked to Helena Laboratories, Corp.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
11
Total Recalls
2017
First Recall
2023
Most Recent
Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blad...
Jun 16, 2023
· Device
Active
V8 Immunodisplacement Kit REF 1803
Apr 6, 2022
· Device
Active
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intende...
Jan 5, 2021
· Device
Terminated
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories...
Sep 27, 2019
· Device
Terminated
ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label...
Aug 8, 2018
· Device
Active
ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label i...
Aug 8, 2018
· Device
Active
Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine...
May 23, 2018
· Device
Active
Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent...
May 23, 2018
· Device
Active
SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415,
for use in the separation and quantitation of hemoglobins by a...
Feb 27, 2018
· Device
Active
SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helen...
Jul 21, 2017
· Device
Terminated