Polymedco, Inc: Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.

Recall number

Z-1059-2013

Recalling firm

Polymedco, Inc

Product

Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.

Status

Terminated

Initiated

2013-02-12

Posted

2013-04-04

Terminated

2016-02-10

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.

Root cause

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

355,350 test strips

Distribution

Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.

Lot, serial or model codes

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.

510(k) numbers

["K041297"]

PMA numbers

not on file

Product code

KHE

Firm FEI

1000119795

Firm city

Cortlandt Manor

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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