Events

Recall of Pointe Scientific Glucose Hexokinase (Hitachi) Reagent (HEX) R1

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
    49466
  • Event Risk Class
    Class 2
  • Event Number
    Z-0219-2009
  • Event Initiated Date
    2008-09-10
  • Event Date Posted
    2008-10-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73488
  • 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
    Reagent Set - Product Code CFR
  • Reason
    The inability of the product to maintain stated performance specifications through the stated shelf life.
  • Action
    Consignees are being notified by letter dated 9/10/08 which will be sent out via fax, email or certified mail to all direct account and drop-ship customers. Customers are advised to dispose of any recalled product found and to consider test results obtained with these lots questionable. Contact Pointe Scientific, Inc. at 1-800-757-5313 or 1-734-487-8300 for assistance.

Device

Pointe Scientific Glucose Hexokinase (Hitachi) Reagent (HEX) R1
  • Model / Serial
    Lots 725701-304, 727501-355, 727501-046, 727501-119 and 727501-205.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, China, Romania and Trinidad.
  • Product Description
    Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R1. (Clinical chemistry)
  • Manufacturer
    Pointe Scientific, Inc.

Manufacturer

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