Events

Recall of Device Recall PTS Panels Creatinine 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
    61966
  • Event Risk Class
    Class 2
  • Event Number
    Z-1903-2012
  • Event Initiated Date
    2012-05-15
  • Event Date Posted
    2012-06-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109606
  • 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 method, creatinine - Product Code JFY
  • Reason
    During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 cardiocek pa meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the cardiochek pa meter for the creatinine assay.
  • Action
    Polymer Technology Systems, Inc sent a URGENT FIELD CORRECTION letter dated May 15, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customers to discontinue use and dispose of the product. PTS Inc. will provide appropriate replacement for any product that is properly identified on the attached Customer Acknowledgement and confirmation letter, If you have any questions please contact Customer Service toll-free at 1-877-870-5610, or +1-317-870-5610 ( outside the US )

Device

Device Recall PTS Panels Creatinine test strips.
  • Model / Serial
    Cat No. 1720; and Lot number F103
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.
  • Product Description
    PTS Panels Creatinine test strips. || PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample
  • 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