Events

Recall of Roche cobas HbA1c tests

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
    15350
  • Event Initiated Date
    2013-09-11
  • 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 advises that the lots specified show imprecision for hba1c patient results. the storage stability data shows a deviation in the range of -10% up to -30% from the target value with an error rate of up to 40%. no deviation was found with previous lots.
  • Action
    Product to be destroyed

Device

Roche cobas HbA1c tests
  • Model / Serial
    Model: Material number: 06378676190, Affected: Lot Numbers: 303022-01, 304021-01, 304022-01, 304023-01, 304024-01, 304025-01, 305021-01, 306022-01, 306023-01, 307021-01
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479