Events

Safety Alert for cobas taqscreen mpx test, version 2.0

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Roche Molecular 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
    2012-10-25
  • Event Date Posted
    2012-10-25
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121025.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: roche cobas taqscreen mpx test, version 2.0 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning cobas taqscreen mpx test, version 2.0, manufactured by roche molecular systems, inc. according to the manufacturer, the package insert, part no. 05969492190, v.2.0, used with the cobas taqscreen mpx test, version 2.0 for use on the cobas s 201 system, ce-ivd contains incorrect specimen transport stability parameters. the living donor specimen transport stability claim in the specimen collection, storage and handling section of the cobas taqscreen mpx test, version 2.0 ce package insert currently allows users to store blood collected in edta, cpd, cpda1 or cp2d for up to 72 hours at 2-30 °c. the package insert will be revised to inform users that blood collected in edta, cpd, cpda1 or cp2d can only be stored for up to 48 hours at 2-25 °c. the manufacturer advised users to immediately take the following actions: users should begin using the new specimen transport conditions as below: blood collected in edta may be stored for up to 48 hours at 2 - 25°c. blood collected in cpd, cpda1 or cp2d may be stored for up to 48 hours at 2 - 25°c. whole blood samples with hcv titers near 20.4 iu/ml or lower stored under conditions stated above, should be reviewed, as, although unlikely, they possibly could have been impacted by this issue. furthermore, product labeling will be updated with the next kit build by the manufacturer. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con195873 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 25 october 2012.

Device

cobas taqscreen mpx test, version 2.0
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Roche Cobas TaqScreen MPX Test, version 2.0
  • Manufacturer
    Roche Molecular Systems

Manufacturer

Roche Molecular Systems