Events

Recall of N Latex ß2–Microglobulin

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-01054-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01054-1
  • 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 received complaints from customers not being able to establish a calibration curve or to validate an established calibration curve with the respective controls when using one of the affected lots of n latex ß2-microglobulin. the issue might lead to the inability to calibrate the assay or to obtain invalid test runs. however, patient results are not affected. there is the potential for the user to be exposed to assay components contaminated with pseudomonas libanensis, pseudomonas rhodesiae and pseudomonas extremorientalis. exposure may lead to an infection and its consequencesa review of previously generated results due to this issue is at the discretion of the laboratory.Siemens advises that the delay of results for these assays does not represent a hazard, and as a result the severity level is none or negligible.
  • Action
    Customers are asked to discontinue use of and discard the affected lots listed in the Customer Letter. A replacement or credit will be issued as per the normal procedure.

Device

N Latex ß2–Microglobulin
  • Model / Serial
    N Latex ß2–Microglobulin Catalogue Numbers: OQWU155 and OQWU15 Lot Numbers: 44862, 44902, 44968, 45192, 45229, 45252, 45291, 45329, 45342, 45366, 45470, 45525 and 45543. ARTG Number: 178153
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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