Events

Recall of AmniSure

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by AmniSure International LLC.

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
    44937
  • Event Risk Class
    Class 2
  • Event Number
    Z-0120-2008
  • Event Initiated Date
    2007-10-03
  • Event Date Posted
    2008-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64550
  • 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
    Fetal Membrane Rupture Test - Product Code JJX
  • Reason
    Weak true postive/false negative results: weak true positive or false negatives in ruptured fetal membranes may occur due to a "hook effect".
  • Action
    AmniSure notified users by Medical Device Correction (Recall) letter dated October 1, 2007 issued via US Mail. The letter provides additional labeling instructions and a checklist for trouble shooting, including a diluation procedure that allows users to determine and solve the problem of the hook effect with this device.

Device

AmniSure
  • Model / Serial
    Lot Number/ Exp. Date  A7003, 01/2009. A7002, 11/2008,  A7001, 10/2008, A6005, 04/2008,  A6004, 01/2008, A6003, 09/2007, and  A6002-3, 09/2007
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, USA, Australia, Austria, Italy, Korea, Bulgaria, Russia, Spain, Kuwait, Switzerland, Luexemburg, Ireland, Denmark, Netherlands, Jordan, Israel, Chile, UK, Singapore, Basil, New Zealand, Turkey, France, Greece, and Equador
  • Product Description
    AmniSure ROM Test, Fetal Membrane Rupture Test for || In-Vitro Diagnostic Use, Model: FMRT-1, AmniSure International LLC, Cambridge, MA 02138
  • Manufacturer
    AmniSure International LLC

Manufacturer

AmniSure International LLC
  • Manufacturer Address
    AmniSure International LLC, 31 Sacramento St # 5, Cambridge MA 02138-1820
  • Manufacturer Parent Company (2017)
    QIAGEN N.V.
  • Source
    USFDA