Events

Recall of NOW

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inverness Medical Professional Diagnostics.

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
    36699
  • Event Risk Class
    Class 2
  • Event Number
    Z-0222-2007
  • Event Date Posted
    2006-11-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49185
  • 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
    In Vitro Diagnostic - Product Code MJH
  • Reason
    Mislabeled product: outer kit label reads now legionella urinary antigen test, inside contains s. pneumonia test pouches.
  • Action
    Binax Inc. DBA Inverness Medical notified consignees by letter on 09/29/06 advising users to return unused product and distributors to recall to the user level.

Device

NOW
  • Model / Serial
    Lot Number: 024448 Exp. Date: March 14, 2008
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, EU, South Korea, Singapore
  • Product Description
    NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use || Product Code: 852-000
  • Manufacturer
    Inverness Medical Professional Diagnostics

Manufacturer

Inverness Medical Professional Diagnostics
  • Manufacturer Address
    Inverness Medical Professional Diagnostics, 10 Southgate Rd, Scarborough ME 04074-8303
  • Source
    USFDA