Events

Recall of MAGNA PURE COMPACT INSTRUMENT

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
    21123
  • Event Risk Class
    III
  • Event Initiated Date
    2010-06-09
  • 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
    Manufacturer internal investigation revealed that the transfer of the nucleic acid contained in the eluates from the reagent cartridge to the elution tube was impacted with a frequency 0f 5%. only a certain portion of the eluated material was transferred to the elution tubes.

Device

MAGNA PURE COMPACT INSTRUMENT
  • Model / Serial
    Model Catalog: 03730972001 (Lot serial: > 10 contact manufacturer); Model Catalog: 04802993001 (Lot serial: > 10 contact manufacturer); Model Catalog: 03730964001 (Lot serial: > 10 contact manufacturer); Model Catalog: 03731146001 (Lot serial: > 10 contact manufacturer)
  • Product Description
    MagNa Pure Compact Instrument
  • Manufacturer
    ROCHE DIAGNOSTICS

Manufacturer

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