Events

Recall of Pointe Scientific Liquid Creatine Kinase Reagent Set

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
    77445
  • Event Risk Class
    Class 3
  • Event Number
    Z-2650-2017
  • Event Initiated Date
    2011-10-19
  • 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=156069
  • 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, cpk or isoenzymes - Product Code CGS
  • Reason
    Linear performance information in product insert does not match that listed in the approved premarket notification.
  • Action
    Pointe Scientific/Technical Bulletin sent notifications on October 19, /2011, 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

Pointe Scientific Liquid Creatine Kinase Reagent Set
  • Model / Serial
    Models: C7522, HC422, HC722, HC922. Lot#'s: 020902; 029902 R1; 029902 R2; 029903; 113204; 129403; 209001. Exp dates 7/2012 to 9/2013.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Pointe Scientific Liquid Creatine Kinase Reagent Set || Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.
  • 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