Events

Recall of Device Recall PTS Panels CHOLHDL Panel 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
    53761
  • Event Risk Class
    Class 3
  • Event Number
    Z-0975-2010
  • Event Initiated Date
    2009-02-20
  • Event Date Posted
    2010-04-02
  • 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=86475
  • 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
    Extended expiration date; the product expired on february 12, 2009 but was labeled with a april 4, 2009 expiration date.
  • Action
    Consignees were notified by letter dated Febuary 20, 2009, advised of the problem, and that the firm would replace product not consumed by the true expiration date. Direct questions to Polymer Technology Systems, Inc.

Device

Device Recall PTS Panels CHOLHDL Panel test strips
  • Model / Serial
    Lot G751.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    PTS Panels CHOL+HDL Panel test strips for professional use with CardioChek P-A analyzer, Manufactured by Polymer Technology Systems, Inc., Indianapolis, IN.Catalog # 1795. || The product is used to measure total cholesterol, and HDL 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