Events

Recall of Device Recall TrepChek Syphilis Test Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diasorin Inc..

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
    31710
  • Event Risk Class
    Class 3
  • Event Number
    Z-0784-05
  • Event Initiated Date
    2005-03-16
  • Event Date Posted
    2005-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38380
  • 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
    Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.
  • Action
    Customers were contacted via telephone, informed of the incorrect package insert, asked to destroy any incorrect inserts and a correct insert was faxed to customers.

Device

Device Recall TrepChek Syphilis Test Kit
  • Model / Serial
    lot # 041207T expiration date 9-30-2005
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MA, CA, TX, KS, NY, FL
  • Product Description
    Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.
  • Manufacturer
    Diasorin Inc.

Manufacturer

Diasorin Inc.
  • Manufacturer Address
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • Manufacturer Parent Company (2017)
    DiaSorin SpA
  • Source
    USFDA