Events

Recall of Device Recall Diamedix IsCMV IgG 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
    73194
  • Event Risk Class
    Class 2
  • Event Number
    Z-1689-2016
  • Event Initiated Date
    2015-03-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145394
  • 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
    Enzyme linked immunoabsorbent assay, cytomegalovirus - Product Code LFZ
  • Reason
    Product contained an incorrect substrate.
  • Action
    On March 26, 2015 Erba Diagnostics sent a communication to their clients informing them of the recall and sending t hem a replacement sustrate HRP to replaced the wrong one sent on the kit.

Device

Device Recall Diamedix IsCMV IgG Test Kit
  • Model / Serial
    Catalog # 720-320 Lot # 10105 Expiration Date January 31, 2016
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, FL, GA, KY, MA, MI, MN, MO, NC, NE, NY, OH, OK, OR, TN, TX, VA, WI and Puerto Rico.
  • Product Description
    Diamedix Is-CMV IgG Test Kit
  • Manufacturer
    Diamedix Corporation

Manufacturer

Diamedix Corporation
  • Manufacturer Address
    Diamedix Corporation, 14100 Nw 57th Ct, Miami Lakes FL 33014-3107
  • Manufacturer Parent Company (2017)
    Diamedix, Inc.
  • Source
    USFDA