Events

Recall of Device Recall Uritek TC101Urine Analyzer, catalog number TC101

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

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
    34304
  • Event Risk Class
    Class 2
  • Event Number
    Z-0472-06
  • Event Initiated Date
    2005-12-22
  • Event Date Posted
    2006-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43507
  • 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
    Automated Urinalysis System - Product Code KQO
  • Reason
    When reading the nitrite parameter on the teco diagnostics urs-10 strips, some positive nitrite samples may be read by the machine as negative.
  • Action
    On December 22nd,2005 the firm sent the notification letter along with a replacement unit of TC-101. These letters and replacement units were send via Fed ex ground and the tracking numbers and serial numbers of the sent units are also noted. Also noted are the return authorization numbers assigned to each respective customer.

Device

Device Recall Uritek TC101Urine Analyzer, catalog number TC101

Manufacturer

Teco Diagnostics
  • Manufacturer Address
    Teco Diagnostics, 1268 N Lakeview Ave, Anaheim CA 92807-1831
  • Source
    USFDA