The Recall Desk

FDA (Devices) recall action 85508

Becton Dickinson & Co. recalled 3 products on 2020-05-27

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-05-27
Critical
0
Units
12,273

Why these products were recalled

May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain

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.

1–3 of 3

  • HighFDA (Devices)··2020-05-27

    Becton Dickinson Recalls BD BBL Gram Crystal Violet Stain Reagent

    Becton Dickinson & Co. is recalling BD BBL Gram Crystal Violet stain because increased artifacts may cause false-positive Gram stain results.

    Product
    BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212526 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-05-27

    Becton Dickinson Recalls BD BBL Gram Crystal Violet Stain Reagent

    Becton Dickinson is recalling BD BBL Gram Crystal Violet stain reagent because it may produce artifacts that look like gram-positive cocci, potentially causing false-positive test results.

    Product
    BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-05-27

    BD BBL Gram Stain Kit Recalled for Potential False-Positive Results

    Becton Dickinson is recalling 1,469 BD BBL Gram Stain Kits because increased artifacts may be mistaken for bacteria, leading to false-positive results.

    Product
    BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For the differential staining of bacteria, Catalog Number: 212539 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
    Category
    Distribution
    0 states