Events

Recall of Device Recall ENA6 Screen 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
    61568
  • Event Risk Class
    Class 2
  • Event Number
    Z-1620-2012
  • Event Initiated Date
    2011-06-08
  • Event Date Posted
    2012-05-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108435
  • 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
    On 06/08/2011 diamedix corporation initiated a recall of is-ena-6 screen test kit, catalog # 720-320 master lot s0000, exp. date may 31, 2012. the labeling on the kit box has an expiration date of 2012-05-31 while the components have an expiration date of 2012-04-30 for an incorrect expiration date.
  • Action
    Diamedix Corporation sent a Customer notification letter dated June 8, 2011, to all affected customers via Certified Mail. Customers were instructed to search their inventory and to return affected product to Diamedix. Diamedix apologizes for any inconvenience this has caused our valued customers. Please contact the Diamedix Technical Service Department at 1-800-327-4565 or 305-324-2300 to arrange for the return and replacement of any kits you might still have of the lot in question. Please rest assured that Diamedix values you as a customer and is in the process of taking the proper corrective and preventive actions.

Device

Device Recall ENA6 Screen Enzyme Immunoassay Test Kit
  • Model / Serial
    Catalog No. 720-230
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- (USA) nationwide including the states of FL, NY, NC, MS, KY, MA and Puerto Rico and the countries of Italy, Chili and Venezuela.
  • Product Description
    Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmful***Lot No: S0000***For In Vitro Diagnostic Use***Caution, consult accompanying documents***Manufacturer DIAMEDIX***a Subsidiary of IVAX Diagnostics, Inc.***Miami, FL 33127 USA-1-800-327-4565***Biohazard***" || For the qualitative screening of human IgG antibodies to extractable nuclear antigens (ENA) in human serum by indirect enzyme immunoassay as an aid in the diagnosis of certain autoimmune disorders. This test system screens for antibodies to Sm, Sm/RNP, SSA, SSB, Scl-70 and Jo-1 in one well. Positive samples should be evaluated further using tests designed for each ENA antibody.
  • Manufacturer
    Diamedix Corporation

Manufacturer

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