Events

Rappel de Urine Reagent Strips (URS) 10 Parameters

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Teco Diagnostics.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    60476
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0512-2012
  • Date de mise en oeuvre de l'événement
    2011-10-14
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-04-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105523
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Automated urinalysis system - Product Code KQO
  • Cause
    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. sampling size submitted for qc testing was insufficient based upon number o.
  • 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
  • Modèle / numéro de série
    Product # 2: URS-II-I00G-00I i. Lot Number: 35224 ii. Expiration Date: 08/2013
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in CA and Poland.
  • Description du dispositif
    Urine Reagent Strips (URS) 11 Parameters || URS-11-100G-001 || 510(K) number: K970250 || Devise Listing number: D072377 || Each Device consists of 100 strips of Urine Reagent Strips 11 parameters packed with a desiccant pouch inside a black bottle with Cortez Diagnostics Label on the bottle and the bottle placed inside a Cortez Diagnostics Box.
  • Manufacturer
    Teco Diagnostics

Manufacturer

Teco Diagnostics
  • Adresse du fabricant
    Teco Diagnostics, 1268 N Lakeview Ave, Anaheim CA 92807-1831
  • Source
    USFDA