Events

Recall of Device Recall Confirm Clearly Smart

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mizuho USA, Inc..

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
    36898
  • Event Risk Class
    Class 3
  • Event Number
    Z-0469-2007
  • Event Initiated Date
    2006-11-17
  • Event Date Posted
    2007-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49537
  • 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
    Human chorionic gonadotropin (HCG) test-Pregnancy Test - Product Code LCX
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide-USA and Canada
  • Product Description
    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.
  • Manufacturer Address
    Mizuho USA, Inc., 12131 Community Rd, Poway CA 92064-8801
  • Source
    USFDA