Events

Recall of PTS Panels Cholesterol test strips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Polymer Technology Systems, 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
    53768
  • Event Risk Class
    Class 2
  • Event Number
    Z-0871-2010
  • Event Initiated Date
    2009-04-02
  • Event Date Posted
    2010-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86486
  • 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
    Enzymatic esterase--oxidase, cholesterol - Product Code CHH
  • Reason
    The memory chip was coded with incorrect product information.
  • Action
    Polymer Technology Systems, Inc. issued an "Urgent - Field Correction" letter dated April 2, 2009. Consignees were advised of the problem and asked to identify how many kits were in inventory so that the firm could replace product. For further information, contact Polymer Technology Systems, Inc. Customer Service at 1-877-870-5610.

Device

PTS Panels Cholesterol test strips
  • Model / Serial
    Lot Number: C908.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    PTS Panels Cholesterol test strips for self-testing or professional use with CardioChek analyzers, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1711. || Intended to provide a quantitative measurement of total cholesterol in whole blood.
  • Manufacturer
    Polymer Technology Systems, Inc.

Manufacturer

Polymer Technology Systems, Inc.
  • Manufacturer Address
    Polymer Technology Systems, Inc., 7736 Zionsville Rd, Indianapolis IN 46268-2175
  • Manufacturer Parent Company (2017)
    Sinocare Inc.
  • Source
    USFDA