Events

Recall of Device Recall Pointe Scientific Liquid Glucose HEX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Pointe Scientific, 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
    35498
  • Event Risk Class
    Class 2
  • Event Number
    Z-1333-06
  • Event Initiated Date
    2006-06-07
  • Event Date Posted
    2006-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46827
  • 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
    in vitro diagnostic - Product Code CFR
  • Reason
    Product does not meet performance specifications through its labeled expiration period.
  • Action
    Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks.

Device

Device Recall Pointe Scientific Liquid Glucose HEX
  • Model / Serial
    Lots 431704, 511901 and 525101.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Canada, China, Panama, Russia and Trinidad.
  • Product Description
    Glucose HEX R2 reagent sold by Pointe Scientific; in vitro diagnostic, Catalog nos 3-HG920-R2, 7-HG920-R2-17, 7-HG920-R2-200 and 7-HG920-R2-300.
  • Manufacturer
    Pointe Scientific, Inc.

Manufacturer

Pointe Scientific, Inc.
  • Manufacturer Address
    Pointe Scientific, Inc., 5449 Research Dr, Canton MI 48188-2261
  • Manufacturer Parent Company (2017)
    Medtest Holdings Inc
  • Source
    USFDA