Events

Recall of Device Recall The Pointe Scientific CKMB Isoenzyme Control

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
    77453
  • Event Risk Class
    Class 3
  • Event Number
    Z-2649-2017
  • Event Initiated Date
    2010-11-22
  • Event Date Posted
    2017-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156078
  • 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
    U.V. Method, cpk isoenzymes - Product Code JHW
  • Reason
    Incorrect control range in product labeling.
  • Action
    On 11/22/2010, TECHNICAL BULLETIN notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities.

Device

Device Recall The Pointe Scientific CKMB Isoenzyme Control
  • Model / Serial
    Model C7562-12 Control Kit. Lot: 013206-260, Expiration Date: 2013-03
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    FL, AR, NICARAGUA, KOREA
  • Product Description
    The Pointe Scientific CK-MB Isoenzyme Control || Pointe Scientific CK-MB Level II Control, || C7562-12 Control Kit
  • 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