Events

Rappel de Urine Specimen Collection Kit

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 Gen-Probe Inc.

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
    68229
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1793-2014
  • Date de mise en oeuvre de l'événement
    2014-04-17
  • Date de publication de l'événement
    2014-06-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127184
  • 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
    Urine collection kit (excludes hiv testing) - Product Code OIE
  • Cause
    Incorrect labeling was used on each pouch of the affected lots of aptima urine specimen collection kits. the outer box of the kits are identified correctly as "aptima urine collection kits"; however, the inner pouches are incorrectly labeled as "aptima unisex swab collection kit for endocervical and male urethral swab specimens.".
  • Action
    Hologic sent a Recall Notice letter dated April 14, 2014 via overnight mail (FedEx) to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter requests customers to: 1. segregate the entire contents of the affected kit lots 2. reconcile and destroy all partial and/or full kits remaining in inventory and to document; the amount destroyed on the Customer Response Form provided with the Recall Notice; 3. if the urine collection kits were further distributed to other collection sites, then to notify them of this issue; and 4. complete and return the Customer Response Form to Technical Support (contact information is provided in the notification letter). For additional information, questions, or concerns, contact Hologic Molecular (Technical) Support. Toll Free: 888-484-4747 Direct: 858-410-8511 Fax: 858-410-8250 Email: molecularsupport@hologic.com

Device

Urine Specimen Collection Kit
  • Modèle / numéro de série
    Catalog #301040.  Lot Numbers: 27231, 27232, 27233, 27234. Expriation Date: 31JAN2015.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Canada (CA), Denmark (DK), France (FR), Germany (DE), and the United States (US), Belgium (BE), United Kingdom (GB).
  • Description du dispositif
    APTIMA Urine Collection Kit; Catalog Number || 301040, Lots 27231, 27232, 27233, and 27234. || Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.
  • Manufacturer
    Gen-Probe Inc

Manufacturer

Gen-Probe Inc
  • Adresse du fabricant
    Gen-Probe Inc, 10210 Genetic Center Dr, San Diego CA 92121-4362
  • Société-mère du fabricant (2017)
    Hologic, Inc.
  • Source
    USFDA