Events

Recall of Mainline hCG Accuracy Check

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
    49100
  • Event Risk Class
    Class 2
  • Event Number
    Z-0528-2009
  • Event Initiated Date
    2008-08-18
  • Event Date Posted
    2009-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72762
  • 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 Radioimmunoassay - Product Code JHI
  • 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 expiration dates.
  • Action
    Consignees were notified via a Medical Device Removal Notice dated 8/18/08 to locate, discontinue use, and return product along with a copy of the letter. The recall was extended to an additional product via letter dated 9/5/08.

Device

Mainline hCG Accuracy Check
  • Model / Serial
    Lots 50074 and 50075.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Belgium and Switzerland.
  • Product Description
    Mainline hCG Accuracy Check, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3c1001.
  • Manufacturer
    Mainline Technology, Inc.

Manufacturer

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