Events

Rappel de Device Recall Confirm Clearly Smart

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 Mizuho USA, 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
    36898
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0469-2007
  • Date de mise en oeuvre de l'événement
    2006-11-17
  • Date de publication de l'événement
    2007-01-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-05-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49537
  • 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
    Human chorionic gonadotropin (HCG) test-Pregnancy Test - Product Code LCX
  • Cause
    False positives-the firm has received a higher than expected rate of complaints regarding false-positive results.
  • Action
    On November 14, 2006, Mizuho USA and SSL decided to cease further distribution of the product, and to contact SSL''s customers and ask them to return any unsold units. Mizuho USA informed SSL Americas by telephone. On November 21, 2006, SSL Americas sent Recall Notification Letters to each of its customers by US First Class, Certified, Return-receipt mail. The letter included a 'Fax Back' Notification to be use by the firm for recall effectiveness checks.

Device

Device Recall Confirm Clearly Smart
  • Modèle / numéro de série
    Confirm Clearly Starter Kits UPC Code 3-02340-30136-7 and Confirm Clearly Refills Kit UPC Code 3-02340-30138-1 (all lots including: Confirm Clearly Starter Kits Lot numbers : LE612, LE613, LF601, LF606, LF612, LG604, LG609, LG616, LH601, LH607, LH610, LH615, LH621, LJ607, LK605 & LK611 Confirm Clearly Refills Kits Lot numbers : LE611, LF603, LF611, LG602, LG605, LG613, LG614, LH602, LH603, LH611, LH612, LH614, LH619, LJ606, LK602 & LK610  Special Pack Deal (6 Starter Kits & 6 Refill Kits) Lot number; LH608
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide-USA and Canada
  • Description du dispositif
    Confirm Clearly Smart Pregnancy Test (Confirm Clearly Starter Kits, Product Code 30136 and Confirm Clearly Refills Kits, Product Code 30138) || Note: || (1) Confirm Clearly Starter Kits: When sold in the U.S., the product consists of a reader and two disposable test sticks; when sold in Canada, the product consists of a reader and one disposable test stick || (2) Confirm Clearly Refills Kits: The refill consists of three disposable test sticks.
  • Manufacturer
    Mizuho USA, Inc.

Manufacturer

Mizuho USA, Inc.
  • Adresse du fabricant
    Mizuho USA, Inc., 12131 Community Rd, Poway CA 92064-8801
  • Source
    USFDA