Events

Recall of Dade Actin FSL Activated Pro Thromboplastin Time (APTT) Reagent. 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-00170-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00170-1
  • 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
    During recent investigations, siemens healthcare diagnostics has observed that the affected lot numbers show an increase in heparin sensitivity over the shelf life, prolonging activated partial pro thromboplastin times (aptt). this issue is demonstrated by testing with dade® citrol® heparin control, low and high.
  • Action
    Siemens is requesting customers to discontinue the use of the affected lots and discard any remaining inventory of the affected lots. A look back of previously reported Dade Actin FSL APTT results is at the discretion of the laboratory.

Device

Dade Actin FSL Activated Pro Thromboplastin Time (APTT) Reagent. An in vitro diagnostic medical d...
  • Model / Serial
    Dade Actin FSL Activated Pro Thromboplastin Time (APTT) Reagent. An in vitro diagnostic medical device (IVD).Lot 547311 (Cat. no. B4219-1 / SMN 10445713)Lot 547312 (Cat. no. B4219-2 / SMN 10445714)Lot 547316 (Cat. no. B4219-2J / SMN 10465681)Lot 547316A (Cat. no. B4219-2 / SMN 10445714)Lot 547316AA (Cat. no. B4219-2J / SMN 10465681)ARTG Number: 178501
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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