Events

Recall of Roche Cobas Sysmex SP-10/ SP-1000 and associated transport systems (AlphaN, HST and XN-9000/3000)

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
    19796
  • Event Initiated Date
    2016-02-27
  • 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
    There have been reports overseas that sample tubes may not be correctly placed back in the rack tube transport (rtt) after the de-capping process. this may result in open tubes being dropped within the cobas p 512 pre-analytical system, contaminating the system and potentially other samples. a false triggering or detection of the “ready” signal from the lifting gripper in the decapper causes the system to register that the motor motion is finished. the system then continues with the next process step and opens the gripper prematurely., this issue may lead to contamination of the instrument and other samples. the risk to operator of contamination is less than remote. however, the contamination of other samples may lead to erroneous sample results with possible inappropriate diagnosis/treatment.
  • Action
    Software to be upgraded

Device

Roche Cobas Sysmex SP-10/ SP-1000 and associated transport systems (AlphaN, HST and XN-9000/3000)

Manufacturer

Roche Diagnostics GmbH