Events

Recall of ROCHE HITACHI - GENTAMICIN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROCHE DIAGNOSTICS.

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
    17730
  • Event Risk Class
    II
  • Event Initiated Date
    2016-06-02
  • 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 reason for the recall is related to potential increased recovery of patient results (approximately 15-20%) while using the online tdm gentamicin assay on roche cobas c311 c501/c502 c701/c702 or modular p platforms in combination with preciset tdm i of specific lots. this issue does not affect the gentamicin reagent used on the cobas integra systems.

Device

ROCHE HITACHI - GENTAMICIN
  • Model / Serial
    Model Catalog: 038000504190 (Lot serial: 11916101); Model Catalog: 038000504190 (Lot serial: 61177901); Model Catalog: 04490843190 (Lot serial: 61178001); Model Catalog: 05841291190 (Lot serial: 61178001); Model Catalog: 04490843190 (Lot serial: 61762401); Model Catalog: 05841291190 (Lot serial: 61762401); Model Catalog: 04490843190 (Lot serial: 61178301); Model Catalog: 05841291190 (Lot serial: 11916601); Model Catalog: 04490843190 (Lot serial: 11916701); Model Catalog: 05841291190 (Lot serial: 11916701); Model Catalog: 04490843190 (Lot serial: 61762301); Model Catalog: 05841291190 (Lot serial: 61762301); Model Catalog: 04490843190 (Lot serial: 11916601); Model Catalog: 05841291190 (Lot serial: 61178301)
  • Product Description
    ROCHE HITACHI - GENTAMICIN;GENT2 (ONLINE TDM GENTAMICIN)
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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