Events

Recall of Mainline confirms pregnancy test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mainline Technology, 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
    54131
  • Event Risk Class
    Class 2
  • Event Number
    Z-1018-2010
  • Event Initiated Date
    2009-10-07
  • Event Date Posted
    2010-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87580
  • 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
    Pregnancy test - Product Code LCX
  • Reason
    Lack of assurance of safety and efficacy: unapproved for marketing in the u.S., non-compliance with cgmp regulations and no stability data to support labeled expirations dates.
  • Action
    Consignees were notified via recall letters dated October 7, 2009 to cease using and to return the recalled products to Mainline Technology. Direct questions about the recall to Mainline Technology by calling 1-800-541-4467 or 1-734-930-2043.

Device

Mainline confirms pregnancy test
  • Model / Serial
    Lot 25310 and 25831.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Belgium and Switzerland.
  • Product Description
    Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. || The product is used as a pregnancy test.
  • Manufacturer
    Mainline Technology, Inc.

Manufacturer

Mainline Technology, Inc.
  • Manufacturer Address
    Mainline Technology, Inc., 3985 Research Park Dr, Ann Arbor MI 48108-2282
  • Source
    USFDA