Events

Recall of RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (An in vitro diagnostic medical device)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Thermo Fisher Scientific Australia Pty Ltd.

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-00063-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-02-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00063-1
  • 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
    Iris international (the manufacturer) has received reports of uncontained debris (part fragments) as a result of rotor breakage and lid failures on similar centrifuge models which use the rt12 rotor and shield. a shield was implemented on similar models and this notification is to inform ssmp users that the shield must be used when operating the centrifuge. there have been no reports of the statspin mp centrifuge failing to contain debris when users operate statspin mp centrifuges according to the statspin mp operator’s manual (doc # 55-001806-001) and rt12 tube rotor instructions (doc # 54-006155-001).
  • Action
    ThermoFisher is providing additional maintainance instructions and updated operators manual. The information included is intended to supplement the current SSMP Operator Manual.

Device

RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (An in vitro diagnostic medical device)
  • Model / Serial
    RT12 Tube Rotor-Kit (RT12) & StatSpin MP Centrifuge (SSMP) (An in vitro diagnostic medical device)RT12 Tube Rotor-Kit (RT12) Catalogue Number: RT12-KIT (REF x00-006152-001), Product Labeling: 54-006155-001StatSpin MP Centrifuge Catalogue Number: SSMP (REF x00-004998-001), Product Labeling: 55-001806-001HAll Serial Numbers
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd