Events

Recall of Device Recall PTS Panels CHOLGLU 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
    79778
  • Event Risk Class
    Class 2
  • Event Number
    Z-1543-2018
  • Event Initiated Date
    2018-03-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163394
  • 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
    System, test, blood glucose, over the counter - Product Code NBW
  • Reason
    Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (august 2018).
  • Action
    Letters will be sent to each ship-to address, as well as each bill-to address via UPS with signature requirement. Customers will be instructed to immediately quarantine and destroy any materials remaining from these two lots.

Device

Device Recall PTS Panels CHOLGLU Test Strips
  • Model / Serial
    Lot # A705  UDI (01)00381931765016(17)180813(10)A705
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England
  • Product Description
    PTS Panels¿ CHOL+GLU Test Strips (REF 1765)
  • 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