Events

Recall of VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C 311 AND C 501/502 SYSTEMS

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
    28349
  • Event Risk Class
    III
  • Event Initiated Date
    2015-09-11
  • 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
    An inaccurately low result was reported for a vancomycin patient sample on cobas c 501. this was confirmed by roche. detailed investigations revealed that the sample contains a component which inhibits the drug labeled enzyme glucose-6-phosphate dehydrogenase (vanc-g6pdh) in the emit assay.

Device

VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C 311 AND C 501/502 SYSTEMS
  • Model / Serial
    Model Catalog: 04491050190 (Lot serial: All lots.); Model Catalog: 04642481190 (Lot serial: All lots.); Model Catalog: 04642490190 (Lot serial: All lots.); Model Catalog: 05842310190 (Lot serial: All lots.)
  • Product Description
    VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C 311 AND C 501/502 SYSTEMS
  • Manufacturer
    ROCHE DIAGNOSTICS GMBH

Manufacturer

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