Events

Recall of Berichrom PAI (Plasmin activator inhibitors). An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd Diagnostics Division.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2013-RN-00447-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-05-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00447-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The incorrect table of assigned values (tav) was provided with the product. the use of the incorrect values for standard 2 will result in slightly increase calibration curves, potentially resulting in decreased values for patient samples. the degree of deviation is less than 10 percent.
  • Action
    Customers who use the manual method to carry out the test are requested to use the assigned values provided in the recall correspondence. The values provided on the Lot Data CD for use with the BCS/BCS XP systems are correct.

Device

Berichrom PAI (Plasmin activator inhibitors). An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Berichrom PAI (Plasmin activator inhibitors). An in vitro diagnostic medical device (IVD)Catalogue number: OWOA15Siemens material number: 10446642Lot number: 541577
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA