Events

Recall of Device Recall BD MAXTM Vaginal Panel

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Co..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78808
  • Event Risk Class
    Class 2
  • Event Number
    Z-0392-2018
  • Event Initiated Date
    2017-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160562
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Vaginitis and bacterial vaginosis nucleic acid detection system - Product Code NSU
  • Reason
    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.
  • Action
    Customers were notified via UPS on 07/18/2017. The recall for BD MAX" Vaginal Panel and BD MAX" UVE Specimen Collection Kit was initiated on July 18, 2017 and expanded to include BD MAX" CT/GC/TV on August 11, 2017. The recall expansion letter to customers was dated 08/14/2017.

Device

Device Recall BD MAXTM Vaginal Panel
  • Model / Serial
    UDI: 30382904433766. All Lot numbers: Not Distributed in US Not Distributed in US
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US and OUS.
  • Product Description
    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.
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.
  • Manufacturer Address
    Becton Dickinson & Co., 7 Loveton Cir, Sparks MD 21152-9212
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA