Events

Recall of ONLINE TDM GENTAMICIN FOR ROCHE/HITACHI 911912 917 & MOD. P

According to Health Canada (via FOI), this recall involved a device in Canada 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
    42100
  • Event Risk Class
    II
  • Event Initiated Date
    2009-10-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The online tdm gentamicin assays may generate falsely elevated control and patient results when used with the current lot of preciset tdm 1 calibrator on the roche/hitachi analyzers.

Device

ONLINE TDM GENTAMICIN FOR ROCHE/HITACHI 911912 917 & MOD. P
  • Model / Serial
    Model Catalog: 03800504190 (Lot serial: All current lots); Model Catalog: 03800504190 (Lot serial: >10 contact mfg); Model Catalog: 04490843190 (Lot serial: All current lots); Model Catalog: 04490843190 (Lot serial: >10 contact mfg)
  • Product Description
    Online TDM Gentamicin For Roche/Hitachi
  • Manufacturer
    ROCHE DIAGNOSTICS GMBH

Manufacturer

ROCHE DIAGNOSTICS GMBH
  • Manufacturer Address
    MANNHEIM
  • Manufacturer Parent Company (2017)
    Roche Holding AG
  • Source
    HC