Events

Recall of Sysmex

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Roche Diagnostics GmbH.

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
    21687
  • Event Initiated Date
    2017-07-14
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Reason
    It has been reported that a possible mix up of results could occur during 'user modification' of a barcode misread in the following circumstances:, 1. di-60 encountered a problem reading the barcode when processing a slide (slide 1) and a picture of the barcode for slide 1 is taken by the di-60., 2. when this occurs the di-60 provides slide 1 with a temporary order id based on the date and time (ie erryyyymmddhhmmss) and the image of the barcode picture (taken in step 1) is stored in the database and displayed in the order data dialogue against this err id., 3. following this, a slide (slide 2) from the slide maker/stainer (sp-10) which has had a barcode misread occurring on the sp-10 and has been.
  • Action
    Manufacturer to issue advice regarding use

Device

Sysmex

Manufacturer

Roche Diagnostics GmbH