FDA-Device2013-04-10Class II
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
Polymedco, Inc
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.
Sold states
Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
Affected count
355,350 test strips
Manufactured in
510 Furnace Dock Rd, N/A, Cortlandt Manor, NY, United States
Products
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1059-2013Don't want to check this manually?
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