Events

Recall of Device Recall Thyrotest TSH POC Rapid membrane test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ThyroTec 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
    37473
  • Event Risk Class
    Class 3
  • Event Number
    Z-0646-2007
  • Event Initiated Date
    2007-01-24
  • Event Date Posted
    2007-03-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50599
  • 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
    In vitro diagnostic - Product Code JLW
  • Reason
    Positive control showed little or no positive line.
  • Action
    On 1/24/07 the recalling firm notified their only customer of the problem. On 2/5/07, the distributor issued recall letters to their customers informing of the problem and the need to destroy the kits. The kits from lot number 02106-06 were returned to the recalling firm.

Device

Device Recall Thyrotest TSH POC Rapid membrane test
  • Model / Serial
    Product Code 1020, Lot numbers 21086-02 expiration 06/08 and Lot number 02106-06 expiration 04/08.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Thyrotest TSH POC Rapid membrane test. In vitro diagnostic.
  • Manufacturer
    ThyroTec Inc

Manufacturer

ThyroTec Inc
  • Manufacturer Address
    ThyroTec Inc, 1801 Horseshoe Pike Ste 1, Honey Brook PA 19344-8500
  • Source
    USFDA