Events

Recall of IsMeasles IgG Enzyme Immunoassay Test Kit

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

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
    50162
  • Event Risk Class
    Class 2
  • Event Number
    Z-0607-2009
  • Event Initiated Date
    2008-10-10
  • Event Date Posted
    2009-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74884
  • 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
    Rubeola (measles) virus serological reagents. - Product Code LJB
  • Reason
    Possible false-negative test results: the sample a diluent lot # 50768 assigned to is-measles igg lot #'s 41108 and 41108b has higher conductivity than normal, which can sporadically interfere with the mago plus/aptus sensing of and picking up of samples. as a result, if the sample is not picked up/processed, it could lead to the possibility of obtaining false negative results in some cases.
  • Action
    Notification of all domestic customers via Certified Mail. Notification of the one international customer via Federal Express.

Device

IsMeasles IgG Enzyme Immunoassay Test Kit
  • Model / Serial
    Lot number 41108 and 41108B
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of England.
  • Product Description
    Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection.
  • Manufacturer
    Diamedix Corporation

Manufacturer

Diamedix Corporation
  • Manufacturer Address
    Diamedix Corporation, 2140 N. Miami Avenue, Miami FL 33127
  • Source
    USFDA