Events

Recall of VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI 912 AND MODULAR P ANALYZERS)

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
    24657
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-26
  • 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
    A reference standardization of the roche vancomycin assays was done by the manufacturer against the reference method. it was decided to correct both methods against the reference method. the cobas integra assay was corrected by a reagent modification. the instruction for use of the vancomycin assays already show a method comparison against cobas integra with the changed formulation which is not yet available on the market. this may lead to the assumption that both methods are comparable and may affect the interpretation of results. since the cobas integra reagent is not yet adapted results generated with cobas integra are still up to 20% higher than with cobas c or modular p systems.

Device

VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI 912 AND MODULAR P ANALYZERS)
  • Model / Serial
    Model Catalog: 04642481190 (Lot serial: all); Model Catalog: 04642490190 (Lot serial: all); Model Catalog: 04491050190 (Lot serial: all)
  • Product Description
    VANCOMYCIN (ONLINE TDM VANCOMYCIN FOR ROCHE/HITAC;VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI CO
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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