The Recall Desk

FDA (Devices) recall action 61769

Becton Dickinson & Co. recalled 2 products on 2012-07-25

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
2012-07-25
Critical
0
Units
539

Why these products were recalled

Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci.

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.

1–2 of 2

  • ModerateFDA (Devices)··2012-07-25

    Becton Dickinson Recalls Gram Crystal Violet Stain Reagents

    Becton Dickinson is recalling Gram Crystal Violet 250 mL reagents due to potential artifacts that may interfere with the identification of microorganisms.

    Product
    Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2012-07-25

    Becton Dickinson Recalls BD Gram Stain Kits Due to Staining Artifacts

    Becton Dickinson is recalling 539 BD Gram Stain Kits because increased artifacts may interfere with the distinction between microorganisms.

    Product
    BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Distribution
    0 states