Events

Recall of IsantiSm 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
    63410
  • Event Risk Class
    Class 2
  • Event Number
    Z-0445-2013
  • Event Initiated Date
    2012-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113710
  • 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
    Extractable antinuclear antibody, antigen and control - Product Code LLL
  • Reason
    Diamedix corporation recalled their is-anti-sm test kit due to the positive control recovering high out of specification.
  • Action
    Diamedix sent a Customer Notification letter to all affected customers via Certified Mail. The letter identifed the affected product. problem and actions to be taken. The letter instructed customers to contact Diamedix Technical Service Department at 1-800-327-4565 or 305-324-2300 to arrange for the return and replacement of any remaining affected product. For questions call 305-324-2314.

Device

IsantiSm test kit
  • Model / Serial
    Catalog # 720-240, Lot # T0401, Expiration Date: November 18. 2012
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including the states: CA, ID, NJ, NY, OH, PA, PR, RI, TN, and TX, FL, and the countries of Italy, Chile and Ecuador
  • Product Description
    The Is-anti-Sm test kits****Catalog No: 720-240*** || Product Usage: || The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA units (EU) per ml determined by comparison to a Calibrator.
  • Manufacturer
    Diamedix Corporation

Manufacturer

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