Events

Safety Alert for vitros 3600 immunodiagnostics system and vitros 5600 integrated system, software version 3.2.2 and below

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Ortho-clinical Diagnostics Inc.

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
    2016-04-14
  • Event Date Posted
    2016-04-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160414.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: ortho-clinical vitros 3600 immunodiagnostics system and vitros 5600 integrated system, software version 3.2.2 and below the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning vitros 3600 immunodiagnostics system and vitros 5600 integrated system, software version 3.2.2 and below, manufactured by ortho-clinical diagnostics inc. product code: 6802783 and 6802413 unique device id: 10758750002979 and10758750002740 according to the manufacturer, a vitros system software timing anomaly has been identified that could cause two different sample metering scenarios that may lead to erroneous results: scenario 1: the vitros system could aspirate sample from an unintended sample container causing assay result(s) obtained from that sample to be incorrectly associated with the intended sample. scenario 2: a sample could be aspirated from a sample container (sample a) and be dispensed into an unintended container (sample b) to be contaminated and diluted by sample a. there is the potential for false negative and false positive results which may lead to an inappropriate diagnosis and patient management leading to serious patient injury. the manufacturer is providing users with interim instructions to follow to decrease the probability of the issues occurring, and can review the affected systems to determine if the errors have occurred. besides, the manufacturer is providing users with a software update (and associated modification modules) as a permanent correction. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00420-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 april 2016.

Device

vitros 3600 immunodiagnostics system and vitros 5600 integrated system, software version 3.2.2 an...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Ortho-clinical VITROS 3600 Immunodiagnostics System and VITROS 5600 Integrated System, software version 3.2.2 and below
  • Manufacturer
    Ortho-clinical Diagnostics Inc

Manufacturer

Ortho-clinical Diagnostics Inc