Events

Recall of Device Recall MagNA Pure

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Corp..

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
    26406
  • Event Risk Class
    Class 2
  • Event Number
    Z-1044-03
  • Event Initiated Date
    2003-06-26
  • Event Date Posted
    2003-07-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27621
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/Data Processing Module, For Clinical Use - Product Code JQP
  • Reason
    A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols.
  • Action
    An urgent product correction letter dated 6/26/03 was sent to each customer advising them not to use DNA protocols until the software update has been installed.

Device

Device Recall MagNA Pure
  • Model / Serial
    All systems using software version 3.0
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada California, Georgia, Illinois, Maine, Michigan, Mississippi, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Wisconsin and Canada.
  • Product Description
    MagNA Pure LC Instrument; Catalog number 2236931.
  • Manufacturer
    Roche Diagnostics Corp.

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Road, Indianapolis IN 46250-0457
  • Source
    USFDA