The Recall Desk

FDA (Devices) recall action 78808

Becton Dickinson & Co. recalled 3 products on 2018-01-31

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
2018-01-31
Critical
0
Units
—

Why these products were recalled

BD recently notified customers in July 2017 regarding an increased rate of unresolved (UNR) and indeterminate (IND) results for the BD MAXTM Vaginal Panel, experienced by some customers. A non-reportable result may lead to repeat of the test and/or re-collection of a specimen.

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

1–3 of 3

  • ModerateFDA (Devices)··2018-01-31

    BD MAX Vaginal Panel Recalled for Unresolved and Indeterminate Results

    Becton Dickinson is recalling BD MAX CT/GC/TV kits due to increased rates of unresolved and indeterminate results, which may require repeat testing.

    Product
    BD MAX" CT/GC/TV. Catalog Number(s): 443824,442970,443590 (RUO).for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-01-31

    BD MAX UVE Specimen Collection Kit Recalled for Test Result Issues

    Becton Dickinson is recalling the BD MAX UVE Specimen Collection Kit because it may cause unresolved or indeterminate test results, potentially requiring re-testing.

    Product
    BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2018-01-31

    BD MAX Vaginal Panel Recalled for Unresolved and Indeterminate Test Results

    Becton Dickinson is recalling the BD MAX Vaginal Panel due to an increased rate of unresolved and indeterminate results, which may require repeat testing.

    Product
    BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for collection and transport of vaginal and endocervical swab specimens, in addition to the preservation of urine from males and females.
    Category
    Distribution
    0 states