The Recall Desk

FDA (Devices) recall action 83930

Helena Laboratories, Corp. recalled 2 products on 2019-12-04

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-12-04
Critical
0
Units
447

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2019-12-04

    Helena Laboratories Recalls Platelet Aggregation Kits Due to Contamination

    Helena Laboratories is recalling Platelet Aggregation Kits because the Collagen Reagent vials may contain particulate matter or microbial growth.

    Product
    Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO…
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2019-12-04

    Helena Laboratories Recalls Collagen Reagent Due to Potential Contamination

    Helena Laboratories is recalling Collagen Reagent kits because vials may contain particulate matter or microbial growth.

    Product
    Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
    Category
    Distribution
    10 states