Events

Recall of IsSyphilis TREPCHEK 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
    30165
  • Event Risk Class
    Class 3
  • Event Number
    Z-0325-05
  • Event Initiated Date
    2003-09-11
  • Event Date Posted
    2004-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35294
  • 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
    Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.
  • Action
    Recall letter dated 10/8/03 was sent, via FEDEX, with replacement conjugate bottles to those accounts reporting remaining stock.The letter requested that the original conjugate bottle, lot number 42023 be discarded and replaced with new conjugate lot #71323z. The letter also included a new inner box label that had the lot number information for the new conjugate bottle.

Device

IsSyphilis TREPCHEK Test Kit.
  • Model / Serial
    The kit lot number is 42003. The conjugate lot number is 42023.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to 54 laboratory accounts throughout the US.
  • Product Description
    The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. || The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade.The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase.
  • Manufacturer
    Diamedix Corporation

Manufacturer

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