Recall of Device Recall Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtest Holdings, 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
    77048
  • Event Risk Class
    Class 2
  • Event Number
    Z-2165-2017
  • Event Initiated Date
    2011-07-08
  • Event Date Posted
    2017-05-26
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2017-06-02
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Nad reduction/nadh oxidation, lactate dehydrogenase - Product Code CFJ
  • Reason
    Pointe scientific lactate dehydrogenase (liquid) reagent set stability claim is not being met.
  • Action
    Pointe Scientific issued field communication alerting end users of the corrected stability claim. To date the firm has sent individualized communications to 100% of end users that received the product and posted the notification to the company website.

Device

  • Model / Serial
    L7572 all configurations
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set || Model Number(s): L7572. || For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.
  • Manufacturer

Manufacturer

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