Events

Recall of Clearview hCG Combo with Reference Line

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Applied Biotech 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
    44894
  • Event Risk Class
    Class 2
  • Event Number
    Z-0244-2008
  • Event Date Posted
    2007-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64492
  • 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
    hCG Combo with Reference Line - Product Code JHI
  • Reason
    Sensitivity: kits contain test devices which may not meet the label claims for sensitivity, therefore use of such devices may produce false negative results with patient samples at or near the limit of detection of the product.
  • Action
    A Product Recall Notification dated 9/28/2006, was provided via fax, email or direct mail to all primary consignees. Customers were instructed to block all stock of affected lots in their warehouses, contact their primary consignees and advise them to discontinue use immediately and dispose of any unused materials; using a fax back form to communicate to the recalling firm the quantity blocked and disposed of so that arrangements could be made for providing replacement product

Device

Clearview hCG Combo with Reference Line
  • Model / Serial
    Model Number: 6028KCV, ABI Lot/Unit Code: 88982
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide: USA and Canada
  • Product Description
    Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 Individually pouched test cassettes with disposable pipettes, 1 Directional Insert; Inverness Medical Professional Diagnostics Group; Marketed by Wampole Laboratories, 2 Research Way, Princeton NJ 08540 USA
  • Manufacturer
    Applied Biotech Inc

Manufacturer

Applied Biotech Inc
  • Manufacturer Address
    Applied Biotech Inc, 10237 Flanders Ct, San Diego CA 92121-2901
  • Source
    USFDA