Helena Laboratories recalls

Helena Laboratories appears in 16 official U.S. recall notices indexed by RecallRadar, most recently on 2023-06-28.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitr…
  FDA Device · Class II · 2023-06-28 · Helena Laboratories
• V8 Immunodisplacement Kit REF 1803
  FDA Device · Class II · 2022-06-15 · Helena Laboratories
• Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of th…
  FDA Device · Class II · 2021-02-17 · Helena Laboratories
• K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING…
  FDA Device · Class II · 2020-12-23 · Helena Laboratories
• Collagen Reagent, Cat
  FDA Device · Class III · 2019-12-04 · Helena Laboratories
• Platelet Aggregation Kit, Cat
  FDA Device · Class III · 2019-12-04 · Helena Laboratories
• SPIFE Alkaline Hemoglobin Kit, Cat
  FDA Device · Class III · 2019-11-13 · Helena Laboratories
• SPIFE ImmunoFix-6 Kit, Cat
  FDA Device · Class II · 2019-10-16 · Helena Laboratories
• Cascade Abrazo aPTT Test Card, Model 5722, For Export Only
  FDA Device · Class II · 2019-10-09 · Helena Laboratories
• Titan Gel Serum Protein Control: SPE Control Cat
  FDA Device · Class II · 2019-09-11 · Helena Laboratories
• ColoCARE, Cat
  FDA Device · Class II · 2019-07-17 · Helena Laboratories
• ColoCARE, Cat
  FDA Device · Class II · 2019-07-17 · Helena Laboratories
• Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The…
  FDA Device · Class II · 2018-12-19 · Helena Laboratories
• Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat
  FDA Device · Class III · 2018-12-12 · Helena Laboratories
• Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
  FDA Device · Class II · 2018-12-12 · Helena Laboratories
• "Free and Total Protein S ELISA Kit" Cat
  FDA Device · Class II · 2018-10-24 · Helena Laboratories