Events

Rappel de Device Recall QuickVue OneStep hCG Urine

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 Quidel Corporation.

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
    57402
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1457-2011
  • Date de mise en oeuvre de l'événement
    2010-11-23
  • Date de publication de l'événement
    2011-03-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-06-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96051
  • 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
    Radioimmunoassay, human chorionic gonadotropin - Product Code JHI
  • Cause
    The recall was initiated after quidel corporation determined that a small number of quickvue one-step hcg urine kits have been incorrectly packaged with quickvue h. pylori gll cassettes inside the kit boxes. these foil pouches and test cassettes are clearly labeled as h. pylori. nevertheless, there is a risk that customers may overlook this labeling.
  • Action
    Quidel Corporation initiated an "Urgent Medical Device Recall" letter on November 23, 2010, with an attached "Distributor Recall Notification Form" to the affected distributor consignees notifying them of this issue and requesting return of all kits from the affected lot. Quidel is further requesting that distributor consignees notify end-users of the issue and request return of kit boxes containing the H. pylori pouched cassettes. The recall notices sent to the distributors were sent via US Postal, certified, with return receipt. The consignees were instructed to: (1) Locate kits with the affected lot number and immediately remove the kits from your existing inventory and place them into a quarantine location, (2) Contact Quidel Corporation for instructions on how to return the kits and obtain replacement product. Quidel Technical Support (800) 874-1517, Monday-Friday, 7am - 5pm PST, (3) Fax the enclosed Inventory Form to Quidel at (858) 431-3522. Indicate the total number of kits currently on hand with lot number 706842 or if you do not have any kits of this lot number remaining in inventory.

Device

Device Recall QuickVue OneStep hCG Urine
  • Modèle / numéro de série
    Lot Number: 706842
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, GA, HI, IL, KS, KY, MA, MD, MN, NC, NJ, NM, NV, OK, OR, PA, TN, TX, UT, VA, and WA and Canada.
  • Description du dispositif
    QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842
  • Manufacturer
    Quidel Corporation

Manufacturer

Quidel Corporation
  • Adresse du fabricant
    Quidel Corporation, 10165 Mckellar Ct, San Diego CA 92121-4201
  • Société-mère du fabricant (2017)
    Quantimetrix Corporation
  • Source
    USFDA