Events

Safety Alert for BD MAX MRSA Assay

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

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
    2014-08-01
  • Event Date Posted
    2014-08-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140801b.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 mrsa assay medical device manufacturer, bd diagnostic systems, has issued a medical device safety alert concerning its bd max mrsa assay [catalogue no.: 442953; unit: 24 each; lot no.: all lots with an expiration date of 2014-01-21 or later]. according to the manufacturer, their investigation of incorrect results related to the college of american pathologists (cap) surveys mrs5-a 2014 and mrs5-b 2014 using the bd-max mrsa assay confirmed that one of the samples for each of the surveys yielded some false positive results. initial analytical testing has demonstrated previously unobserved cross-reactivity due to non-specific binding with certain methicillin-sensitive staphylococcus aureus (mssa) strains, primarily when these organisms are present at high loads (> 1 x 106 cfu/swab). based on the manufacturer’s assessment of the likelihood of a false positive result, as well as documented performance at customer sites, the assay continues to meet clinical performance claims. while there is the potential for a false positive result for specimens from patients who are positive for certain strains of mssa when present at high loads, the manufacturer believes that such an occurrence is unlikely and overall clinical performance would not be affected. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 01 aug 2014.

Device

BD MAX MRSA Assay
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BD MAX MRSA Assay
  • Manufacturer
    BD Diagnostic Systems

Manufacturer

BD Diagnostic Systems