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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 Device Recall OC Light Manual iFOBT stripssee related information
Date Initiated by FirmFebruary 12, 2013
Date PostedApril 04, 2013
Recall Status1 Terminated 3 on February 10, 2016
Recall NumberZ-1059-2013
Recall Event ID 64537
510(K)NumberK041297 
Product Classification Reagent, occult blood - Product Code KHE
ProductTest 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.
FEI Number 1000119795
Recalling Firm/
Manufacturer		 Polymedco, Inc
510 Furnace Dock Rd
Cortlandt Manor NY 10567-6220
For Additional Information ContactMs. 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		Process control
ActionPolymedco 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 Commerce355,350 test strips
DistributionWorldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KHE
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