Events

Recall of RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 alcohol swab, 1 buffer container, 1 lancet (needle), 1 zipped bag, 1 pipette (plastic) (included with cassette). There is no firm identified on the product packaging.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ups Supply Chain Solutions.

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
    31097
  • Event Risk Class
    Class 2
  • Event Number
    Z-0542-05
  • Event Initiated Date
    2005-02-04
  • Event Date Posted
    2005-02-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37141
  • 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
  • Reason
    The kits are not approved for use in the united states.
  • Action
    Letters dated February 4, 2005, flagged 'Important Safety Notice -- Test Kit Recall' with instructions to consumers to destroy kits and to consult a health care professional if they have used the test kit. Letters will require a signed receipt. Letterhead used identifies recalling firm as 'FDTS'.

Device

RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 ...
  • Model / Serial
    All lots are subject to recall.
  • Distribution
    Consumers throughout the United States.
  • Product Description
    RAPID SYPHILIS TEST KIT, per insert, contents of the kit are: 1 Rapid Syphilis test cassette, 1 alcohol swab, 1 buffer container, 1 lancet (needle), 1 zipped bag, 1 pipette (plastic) (included with cassette). There is no firm identified on the product packaging.
  • Manufacturer
    Ups Supply Chain Solutions

Manufacturer

Ups Supply Chain Solutions
  • Manufacturer Address
    Ups Supply Chain Solutions, 12380 Morris Rd, Alpharetta GA 30005-4177
  • Source
    USFDA