Events

Recall of Device Recall TREPCHEK

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
    28083
  • Event Risk Class
    Class 2
  • Event Number
    Z-0513-04
  • Event Initiated Date
    2003-12-09
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31165
  • 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 Immunoabsorption Assay, Treponema Pallidum - Product Code LIP
  • Reason
    The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
  • Action
    A recall notification letter was mailed to each consignee/user account on 12/9/2003 telling them that the recalled lot may give a higher frequency of equivocal/weak positive results. It requests them to discontinue use and to return the product to them. Also they are asked to sign and date the bottom of the recall letter and fax it back to the recalling firm.

Device

Device Recall TREPCHEK
  • Model / Serial
    Lot Number 71303, expiration date June 2004
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to three hospitals/clinics in AZ, CA and TX.
  • Product Description
    Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127
  • Manufacturer
    Diamedix Corporation

Manufacturer

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