Events

Recall of Device Recall Pointe Scientific Chemistry Controls Level I and II

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
    77083
  • Event Risk Class
    Class 3
  • Event Number
    Z-2121-2017
  • Event Initiated Date
    2014-05-15
  • Event Date Posted
    2017-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154940
  • 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
    Multi-analyte controls, all kinds (assayed) - Product Code JJY
  • Reason
    The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
  • Action
    Customers were notified on 05/5/14by sending a technical bulletin (via email, fax, US Mail and posting on website) to all customers and distributors that had received lot 303104 of C7590, lot 303105 of C7591 or C7592 kits with either lot since product was approved to ship. All product shipped after 05/15/2014 included the updated package inserts. Any questions concerning the implementation of the new controls ranges may be directed to Pointe Scientific's Technical Service Department at 1-800-757-5313. Thank you for your continued support of Pointe Scientific.

Device

Device Recall Pointe Scientific Chemistry Controls Level I and II
  • Model / Serial
    Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Pointe Scientific Chemistry Controls Level I and II || LEVl: Amber glass vial w/PP white plastic cap. || LEV2: Amber glass vial w/PP black plastic cap.
  • Manufacturer
    Medtest Holdings, Inc.

Manufacturer

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