Events

Recall of Device Recall Pointe Scientific

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
    35499
  • Event Risk Class
    Class 2
  • Event Number
    Z-1543-06
  • Event Initiated Date
    2006-06-09
  • Event Date Posted
    2006-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46269
  • 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
    Ammonia/alcohol assay - Product Code JIX
  • Reason
    Open vial stability-potential microbial growth in the alcohol standard and possible unexpected qc changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
  • Action
    Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.

Device

Device Recall Pointe Scientific
  • Model / Serial
    Lot 522202, exp. 7/06.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- including USA and countries of Canada, Ecuador, Germany, Greece, India, Mexico, Peru, Poland, Portugal, Trinidad, United Arab Emirates and United Kingdom.
  • Product Description
    Alcohol Control, Level 2 sold by Pointe Scientific; Catalog # 7-A7504-CTL-L2.
  • Manufacturer
    Pointe Scientific, Inc.

Manufacturer

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