Events

Recall of Device Recall Pointe Scientific, Med Test, Pointe Scientific autoHDL Reagent

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
    71953
  • Event Risk Class
    Class 3
  • Event Number
    Z-2764-2015
  • Event Initiated Date
    2015-03-13
  • Event Date Posted
    2015-09-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139474
  • 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
    Ldl & vldl precipitation, hdl - Product Code LBR
  • Reason
    Crystals may be observed in the r1 reagent. crystals may be a result of the reagent being frozen during transport. the crystals do not impact product performance.
  • Action
    Pointe Scientific sent a Field Correction Notice on March 13, 2015, to all affected customers via fax, email, and mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Technical Service Department at 1-800-757-5313.

Device

Device Recall Pointe Scientific, Med Test, Pointe Scientific autoHDL Reagent
  • Model / Serial
    Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.
  • Product Description
    Pointe Scientific autoHDL Reagent H7545 || H7545-R1 in a bulk cube container or HDPE plastic bottle || H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 || 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 || HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 || Kits: HDPE plastic bottle, PP plastic caps. || Bulk: PE plastic cube containers, PP plastic caps. || Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.
  • 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