Events

Recall of Device Recall CardioChek PTS Panels CHOLHDLGLU

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
    56188
  • Event Risk Class
    Class 2
  • Event Number
    Z-2641-2010
  • Event Initiated Date
    2010-07-06
  • Event Date Posted
    2010-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92892
  • 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
    blood glucose test system - Product Code NBW
  • Reason
    The test strips appear to under-recover cholesterol, hdl and glucose.
  • Action
    Distributors and direct customers were notified by letter on July 2, 2010. They were told to discontinue use and dispose of the affected lot of test strips. The firm also asked customers to complete an acknowledgement and confirmation document .

Device

Device Recall CardioChek PTS Panels CHOLHDLGLU
  • Model / Serial
    Lot number I904
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US accounts in: CA, MA, FL, NY, KY, VA, UT, MN, OH, and MD. Direct foreign accounts in: Belgium, England, Sweden, and Italy.
  • Product Description
    PTS Panels Test Strips, CHOL +HDL+GLU Panel for CardioChek PA brand analyzers, 15 tests 1 MEMo Chip, manufacturer Polymer Technology Systems, Inc., 7736 Zionsville Rd., Indianapolis, IN 46268.
  • 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