Events

Recall of Roche Elecsys CMV IgM, diluent universal

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
    18119
  • Event Initiated Date
    2015-02-20
  • 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
    Internal investigations demonstrate that some lots of diluent universal may have an influence on the cmv igm results and may lead to low or false negative results with specific lots of the the elecsys cmv igm assay., a certain lot of a specific component used in the diluent universal caused the signal reduction of an internal control sample in the elecsys cmv igm assay. this internal control sample showed a high reactivity against one specific antigen included in the cmv igm assay.
  • Action
    Manufacturer to issue advice regarding use

Device

Roche Elecsys CMV IgM, diluent universal
  • Model / Serial
    Model: Order codes: 04784618190, 03183971122, 11732277122, Affected: Lots: (04784618190) 179689; (03183971122) 175913, 178383, 178386; (11732277122) 176099, 176899
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479