Z-1059-2013Class II

Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative...

Name: Z-1059-2013 Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative...
Creator: Polymedco, Inc
Published: 2013-02-12
License: https://open.fda.gov/license/

Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC / initiated 2013-02-12 / Terminated / root cause: manufacturing process

FDA source

Polymedco, Inc began a recall of Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces on 2013-02-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1059-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-12
Posted: 2013-04-04
Terminated: 2016-02-10
Recalling firm: Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, LLC
Product: Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
Product code: KHE Reagent, Occult Blood
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 355,350 test strips
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1059-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1059-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-04
Z-1060-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-04

Product code KHE

K041297Class IIPolymedco Oc Light Fobt TestPolymedco, Inc. / cleared 2004-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)