Date Initiated by Firm |
February 12, 2013 |
Date Posted |
April 04, 2013 |
Recall Status1 |
Terminated 3 on February 10, 2016 |
Recall Number |
Z-1059-2013 |
Recall Event ID |
64537 |
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 NY 10567-6220
|
For Additional Information Contact |
Ms. 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 |
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
|
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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) Database |
510(K)s with Product Code = KHE and Original Applicant = POLYMEDCO, INC.
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