Events

Recall of Device Recall MagNA Pure LC

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
    26366
  • Event Risk Class
    Class 2
  • Event Number
    Z-1001-03
  • Event Initiated Date
    2003-05-27
  • Event Date Posted
    2003-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27570
  • 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
  • Reason
    Potential for false negative patient results with software version 3.0.
  • Action
    An Urgent Product Correction letter dated 5/27/03 was sent to each customer.

Device

Device Recall MagNA Pure LC
  • Model / Serial
    All units with software version 3.0.
  • Distribution
    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