Events

Recall of Roche ProCell/CleanCell Aspiration Tube Filters

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by manufacturer #1479.

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
    16654
  • Event Initiated Date
    2014-05-08
  • 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 identified that under certain conditions the white aspiration tube/filters on the end of the procell and cleancell aspiration tubes may become loose or fall off the aspiration tube completely. this in turn may allow air to enter the aspiration tube, creating foam. the liquid short sensors (lss) are unable to detect these very small bubbles. foam may be visible in the procell and cleancell reservoirs. if foam reaches the measuring cells, this may cause discrepant results. the magnitude of the discrepancy will vary with the amount of air being aspirated, particularly for procell.
  • Action
    Instructions for use to be updated

Device

Roche ProCell/CleanCell Aspiration Tube Filters
  • Model / Serial
    Model: Part number: 03149773001, Affected: All lots
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479