Events

Recall of N Latex ß2–Microglobulin. An in vitro diagnostic medical device (IVD)(Quality control reagent)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare 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-00682-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-07-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00682-1
  • 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 confirmed complaints about calibration/qc validation issues as well as 'abnormal assay error' flags when using the affected lots. affected reagent vials and reagent flexes show partial flocculation and share the same production bulk.
  • Action
    Siemens is requesting their customers to discontinue use and discard the affected lots. This action has been closed-out on 06/07/2017.

Device

N Latex ß2–Microglobulin. An in vitro diagnostic medical device (IVD)(Quality control reagent)
  • Model / Serial
    N Latex ß2–Microglobulin. An in vitro diagnostic medical device (IVD)(Quality control reagent)Catalogue Number: OQWU155 Kit Number: 44696, 44800, and 44834Catalogue Number: OQWU215 Kit Number: 44697ARTG Number: 178153
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA