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Polymedco, Inc recalls Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of hum
Recalled April 10, 2013 · FDA recall Z-1059-2013 · Polymedco
Hazard
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 Class II
Units
355,350 test strips
Sold at
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
Description
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.
Product
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
Manufacturer(s)
Polymedco, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →