Events

Recall of InSure(R) Quik FIT(TM)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Enterix, 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
    49560
  • Event Risk Class
    Class 2
  • Event Number
    Z-0480-2009
  • Event Initiated Date
    2008-10-03
  • Event Date Posted
    2008-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73812
  • 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
    Occult Blood Test - Product Code KHE
  • Reason
    False readings: reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. for further information, please contact enterix, inc. at 1-800-531--3681.
  • Action
    Medical Device Recall Letters were sent on October 3, 2008 to all customers by certified mail. The letters were entitled "URGENT *** MEDICAL DEVICE RECALL (U.S. ONLY). Questions are to be directed to Enterix at 1-800-531-3681,

Device

InSure(R) Quik FIT(TM)
  • Model / Serial
    Lot number B1478, Exp. Date 11/30/2008
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to medical facilities and laboratories throughout the US.
  • Product Description
    INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits. || Product Number 30025 - InSure(R) Quik FIT)TM) Developer Kit (1 Box) . Each box contains: 25 InSure(R) Quik FIT(TM) Test Strips (1 per foil pack), 1 InSure(R) Quik FIT(TM) Conjugate Solution, I InSure(R) Quik FIT(TM) Run Buffer, and 1 InSure(R) Quik FIT(TM) Product Instructions. || Product 50025 - InSure(R) Quik FIT(TM) contains 25 Patient Kits & 1 Developer Kit.
  • Manufacturer
    Enterix, Inc.

Manufacturer

Enterix, Inc.
  • Manufacturer Address
    Enterix, Inc., 236 Fernwood Ave, Edison NJ 08837-3839
  • Manufacturer Parent Company (2017)
    Enterix Inc.
  • Source
    USFDA