Events

Recall of cobas e 801 syringe plunger issue

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
    22805
  • Event Initiated Date
    2018-04-13
  • 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
    The manufacturer has received complaints describing an issue with the syringe plunger on the cobas e 801 module prewash syringe assembly. investigations determined that the issue may also occur on the cobas e 801 module r1 or r2 reagent assembly. depending on the affected syringe, r1, r2 or prewash, liquids may not be pipetted correctly due to the syringe plunger being damaged. depending on how the seal pieces are assembled, it is possible that the plunger is mounted in a tilted position, which applies mechanical stress to the plunger. during the cobas e 801 module initialization steps when the largest stokes happen, the plunger may crack leading to an impaired syringe function.
  • Action
    Product to be modified

Device

cobas e 801 syringe plunger issue

Manufacturer

Roche Diagnostics GmbH