Events

Recall of Device Recall Mainline Confirms Strep A,

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
    49082
  • Event Risk Class
    Class 2
  • Event Number
    Z-2427-2008
  • Event Initiated Date
    2006-11-08
  • Event Date Posted
    2008-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-03-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72721
  • 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
    Streptococcusspp serological reagents. - Product Code GTY
  • Reason
    Use of an incorrect dropper tip on the dispenser may result in false positive a streptococcal results.
  • Action
    Consignees were notified by phone and follow-up letter on or about 11/6/06 advising them of the problem. Consignees were give the option of returning the product and receiving the correct tip, or keeping the product and adding extra drops. Additional written notice was provide to each consignee.

Device

Device Recall Mainline Confirms Strep A,
  • Model / Serial
    Lot No: 94300.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs, Mainline Technology, Inc., Ann Arbor, MI; Cat. Nos. 3030-20 (20 test) and 3030-40 (40 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