Events

Safety Alert for BD MAX System Software Version 4.44A

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
    2015-08-05
  • Event Date Posted
    2015-08-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150805.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 system software version 4.44a medical device manufacturer, bd, has issued a medical device safety alert concerning its bd max system software version 4.44a [serial number: ct0583]. the manufacturer has determined that bd max system software version 4.44a contains a software anomaly that has the potential to affect some open system reagent (osr) customers utilizing user defined protocol (udp) assays. affected users utilizing only ivd assays are not affected. this anomaly may cause the osr customer system to incorrectly switch the columns of the truth table on the user’s display. if the user tries to fix their display data, the display will appear correct however, the database may become incorrect, potentially resulting in incorrect results reporting. the manufacturer is currently developing and validating an update to the software to correct this issue. the new software will be available by the end of august 2015. until the software can be updated on the affected instrument, users are reminded to follow osr workflow instructions to ensure that the above-described situation does not occur. no action is required for ivd assay users. 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 05 august 2015.

Device

BD MAX System Software Version 4.44A
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BD MAX System Software Version 4.44A
  • Manufacturer
    BD

Manufacturer

BD