||April 04, 2013
||Terminated on February 10, 2016
|Recall Event ID
Reagent, occult blood -
||Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR.
For the rapid, qualitative detection of human hemoglobin in feces.
||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.
510 Furnace Dock Rd
|For Additional Information Contact
||Ms. Helen Landicho
|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.
||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.
|Quantity in Commerce
||229,600 test strips
||Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.