Events

Recall of Device Recall OC Light Manual iFOBT strips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Polymedco, 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
    64537
  • Event Risk Class
    Class 2
  • Event Number
    Z-1060-2013
  • Event Initiated Date
    2013-02-12
  • Event Date Posted
    2013-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116485
  • 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
    Reagent, occult blood - Product Code KHE
  • Reason
    The test strips in the affected product lots of the oc light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. there may be a possibility of obtaining false negative results when using the affected lots.
  • Action
    Polymedco initiated phone calls to clients on 2/12/13. When the contact was made with the client, an URGENT DEVICE RECALL letter and Fax Form were sent by e-mail/fax. Mass mailing of the URGENT DEVICE RECALL letter dated February 12, 2013 and Fax Form was done by First Class USPS on 2/14/13-2/18/13. The recall affects the test strips only. For questions, please contact Polymedco Technical Support at 1-800-431-2123 ext 285.

Device

Device Recall OC Light Manual iFOBT strips
  • Model / Serial
    Kit Lot # P207830 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18005M;  Kit Lot # P210191 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M Kit Lot # P210192 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M;  Kit Lot # P217033 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y011M;  Kit Lot # P217034 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M;  Kit Lot # P217035 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M;  Kit Lot # P222808 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
  • Product Description
    Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. || For the rapid, qualitative detection of human hemoglobin in feces.
  • Manufacturer
    Polymedco, Inc

Manufacturer

Polymedco, Inc
  • Manufacturer Address
    Polymedco, Inc, 510 Furnace Dock Rd, Cortlandt Manor NY 10567-6220
  • Manufacturer Parent Company (2017)
    Polymedco Inc.
  • Source
    USFDA