Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
FDA Recall Z-1059-2013 · Posted 2013-04-04
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Recalling FirmPolymedco, Inc
Recall StatusTerminated
Product CodeKHE
Date Initiated2013-02-12
Date Terminated2016-02-10
Product Quantity355,350 test strips
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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