Events

Safety Alert for BD MAX Vaginal Panel and BD MAX UVE Specimen Collection Kit

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by BD.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-07-31
  • Event Date Posted
    2017-07-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170731.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: bd max vaginal panel and bd max uve specimen collection kit medical device manufacturer, bd, has issued a medical device safety alert concerning its bd max vaginal panel [catalogue number: 443712, 443710] and bd max uve specimen collection kit [catalogue number: 443376]. the manufacturer is currently conducting an investigation into customer complaints regarding an increased rate of unresolved (unr) and indeterminate (ind) results for the bd maxtm vaginal panel. a non-reportable result may lead to repeat of the test and/or re-collection of a specimen. data from the investigation suggest that this issue is related to certain specimen collection practices, including the use of lubricants. information is intended to provide clinicians and patients with precautions in relation to current package insert instructions included with bd max uve specimen collection kits. product returns or discards are not required. clinicians and patients are advised to follow the precautions provided by the manufacturer. according to the local supplier, the affected products are distributed in hong kong if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 july 2017.

Device

BD MAX Vaginal Panel and BD MAX UVE Specimen Collection Kit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BD MAX Vaginal Panel and BD MAX UVE Specimen Collection Kit
  • Manufacturer
    BD

Manufacturer

BD