Events

Recall of Cobas modular analytic series system

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Patheon API Inc..

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
    21590
  • Event Initiated Date
    2017-06-28
  • 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 Consumer Health, Division of Roche Products (NZ) Limited, 8 Henderson Place, Te Papapa, AUCKLAND
  • Reason
    In very rare cases when a number of specific conditions are met, it is possible that a sample mismatch may occur in the immunochemistry modules (cobas e 602, cobas e 601 and e170 modules) due to a software limitation. if the gripper fails to pick up a sample vessel (cup) for a sample on the rack being assayed, the measurement for that sample is cancelled and the warning "tip/cup pick up error" (caution level) is issued.
  • Action
    Product to be modified

Device

Cobas modular analytic series system
  • Model / Serial
    Model: , Affected: Immunochemistry module cobas e 602, cobas e 601 and E170 modules, cobas 8000 modular analyzer series, cobas 6000 analyzer series, MODULAR ANALYTICS, MODULAR ANALYTICS EVO
  • Manufacturer
    Patheon API Inc.

Manufacturer

Patheon API Inc.