Events

Recall of Urine Reagent Strips (URS) 10 Parameters

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
    60476
  • Event Risk Class
    Class 2
  • Event Number
    Z-0511-2012
  • Event Initiated Date
    2011-10-14
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105522
  • 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
    This recall was initiated in response to findings during a fda inspection of the firm. the firm's recall has been initiated due to improper manufacture of sub-component nitrite paper lot 35134, expiration date: 01/2014. discrepancies were found on the information recorded on formulation sheet and manufacturing log sheets (refer to next paragraph). sampling size submitted for qc testing was insuff.
  • Action
    Teco Diagnostics sent an "URGENT: MEDICAL DEVICE RECALL" letter dated October 14, 2011 to affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed customers to examine their inventory for the affected product and to quarantine any product found. A Recall Return Response Form was included with the letter for customers to complete and return. Contact the firm's Technical Support Department at (800) 222-9880 for questions regarding this recall.

Device

Urine Reagent Strips (URS) 10 Parameters
  • Model / Serial
    Product/Catalog # 1: URS-l 0-100W i. Lot Number: 35264 ii. Expiration Date: 01/2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in CA and Poland.
  • Product Description
    Urine Reagent Strips (URS) 10 Parameters || URS-l0-100W || 510(K) number: K970250 || Devise Listing number: D072377 || Each device consists of 100 strips of Urine Reagent Strips 10 parameters || packed with a desiccant pouch inside a gray bottle with Teco Diagnostics || Label on the bottle and the bottle placed inside a Teco Diagnostics Box. || For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in urine.
  • Manufacturer
    Teco Diagnostics

Manufacturer

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