Events

Recall of Pointe Scientific Liquid Glucose (HEXO) Reagent Set

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
    53583
  • Event Risk Class
    Class 1
  • Event Number
    Z-0104-2010
  • Event Initiated Date
    2009-10-19
  • Event Date Posted
    2009-11-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85912
  • 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
    Glucose Hexokinase - Product Code CFR
  • Reason
    There is a loss of linearity. the product fails to maintain linearity specification of 500 mg/dl.
  • Action
    The firm issued a press release, and an amended press release, on 10/30/09. Consignees were notified by an Urgent: Medical Device Recall letter dated 10/19/09, which identified the problem; and, instructed testing laboratories to inform patients' attending physicians, and determine, with their input, whether confirmation of the previous test results will be required. Customers are to examine their inventory for any of the lot numbers listed on the letter; and, for any product that has been further distributed, those customers need to be identified and notified of this product recall by including a copy of the recall letter. Customers are to complete and return the Recall Return Response form and upon receipt, Pointe Scientific will replace any disposed of reagent. The recall was expanded to include two additional lots by letter dated 11/2/09.

Device

Pointe Scientific Liquid Glucose (HEXO) Reagent Set
  • Model / Serial
    All lots beginning with the numbers 814301, 820502, 823901, 826801, 829401, 814301, 820502, and 831502.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Israel, Mexico, South Africa, and West Indies.
  • Product Description
    Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical chemistry) || Pointe Scientific Liquid Glucose (HEXO) is used for the quantitative determination of glucose in serum.
  • 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