Reported Apr 10, 2013 · Terminated
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human…
Polymedco, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Polymedco, Inc · 510 Furnace Dock Rd · Cortlandt Manor, NY · 10567-6220
Is this the product you have?
- Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
- Lot codes and dates
12 of 12 products
Products covered by this recall # Product as published 1 Kit Lot # P205877 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18004M 2 Kit Lot # P210125 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M 3 Kit Lot # P210204 - Kit Expiration Date 3/31/2013 - Test Strip Lot # 19006M 4 Kit Lot # P212420 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M 5 Kit Lot # P212421 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M 6 Kit Lot # P210194 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M 7 Kit Lot # P217043 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M 8 Kit Lot # P234499 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 25011M 9 Kit Lot # P234664 - Kit Expiration Date 11/30/2013 - Test Strip Lot # 26012M 10 Kit Lot # P238025 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M 11 Kit Lot # P238028 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26013M 12 Kit Lot # P243938 - Kit Expiration Date 12/31/2013 - Test Strip Lot # 26012M. - Amount recalled
- 355,350 test strips
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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