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U.S. Department of Health and Human Services

Class 2 Device Recall OC Light Manual iFOBT strips

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 Class 2 Recall
OC Light Manual iFOBT strips
see related information
Date Posted April 04, 2013
Recall Status1 Open
Recall Number Z-1059-2013
Recall Event ID 64537
Premarket Notification
510(K) Number
K041297 
Product Classification Reagent, Occult Blood - Product Code KHE
Product Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
Code Information Kit Lot # P205877 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18004M; Kit Lot # P210125 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M; Kit Lot # P210204 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M; Kit Lot # P212420 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M; Kit Lot # P212421 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M; Kit Lot # P210194 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217043 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P234499 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 25011M; Kit Lot # P234664 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 26012M; Kit Lot # P238025 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M; Kit Lot # P238028 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26013M; Kit Lot # P243938 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M.
Recalling Firm/
Manufacturer
Polymedco, Inc
510 Furnace Dock Rd
Cortlandt Manor, New York 10567-6220
For Additional Information Contact Helen Landicho
914-739-5400
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
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.
Quantity in Commerce 355,350 test strips
Distribution 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.
510(K) Database 510(K)s with Product Code = KHE and Original Applicant = POLYMEDCO, INC.
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