Events

Recall of COBAS MIRA SYSTEM - LIPASE ASSAY

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
    54858
  • Event Risk Class
    III
  • Event Initiated Date
    2015-07-03
  • 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 manufacturer has identified that the lipase assay was showing occasionally calibration and qc failures associated to on-board reagent stability that have trigger the need to have the reagent shelf-life to be reduced from 15 to 9 months.

Device

COBAS MIRA SYSTEM - LIPASE ASSAY
  • Model / Serial
    Model Catalog: 07041918190 (Lot serial: All lots); Model Catalog: 11821792216 (Lot serial: All lots); Model Catalog: 11821822216 (Lot serial: All lots)
  • Product Description
    COBAS MIRA SYSTEM - LIPASE ASSAY
  • Manufacturer
    ROCHE DIAGNOSTICS GMBH

Manufacturer

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