Events

Recall of Siemens Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries(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-2015-RN-00084-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00084-1
  • 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
    Siemens healthcare diagnostics has identified that a material change made by the supplier has resulted in capillary caps that are more difficult to apply to the capillaries. attempting to apply these capillary caps to the capillaries could result in spillage of the sample or possible breakage of the glass capillary.
  • Action
    Siemens is advising the customers that they use caution when applying the Capillary Caps with Siemens Multicap glass and Multicap-S plastic capillaries to minimize the potential for breakage or bending. Siemens will be providing new Capillary Caps for the capillary blood collection products by February / March 2015. This action has been closed-out on 20/04/2017.

Device

Siemens Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries(An in v...
  • Model / Serial
    Siemens Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries(An in vitro diagnostic medical device (IVD))Siemens Material Numbers: 10311053, 10311054 and 10328655Legacy Part Number: 478601, 478605 and 478527ARTG number: 174701
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

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