Events

Recall of Device Recall Legionella ELISA Test System

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
    31078
  • Event Risk Class
    Class 3
  • Event Number
    Z-0541-05
  • Event Initiated Date
    2004-12-23
  • Event Date Posted
    2005-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37115
  • 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
    Reagents, Antibody, Legionella, Direct & Indirect Fluorescent - Product Code LHL
  • Reason
    The kits belonging to lot #s 30804/30804z and 91803z may lose activity, after one or two usages, causing the od values for the cut-off calibrator and/or positive control to be recovered below their specified ranges.
  • Action
    Direct customers were notified by letter on 12/23/2004 by Federal Express.100% of the total customers will be contacted. The letter instructed the consignees to discontinue use immediately and arrange to return the product to Diamedix.

Device

Device Recall Legionella ELISA Test System
  • Model / Serial
    Lot # 91803Z and 30804/30804Z
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to Domestic customers only.
  • Product Description
    The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.
  • Manufacturer
    Diamedix Corporation

Manufacturer

Diamedix Corporation
  • Manufacturer Address
    Diamedix Corporation, 2140 N Miami Ave, Miami FL 33127-4916
  • Source
    USFDA