FDAFDA · Alimentos y medicamentos·N.º oficial Z-1060-2013
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. For the rapid, qualitative detection of human hemoglobin in feces.
Publicado el 10 de abril de 2013 · Inicio del retiro: 12 de febrero de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Telephone
Detalles del retiro
- Fabricante
- Polymedco, Inc
- Distribuidor
- Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada and Guam.
- Lote
- Kit Lot # P207830 - Kit Expiration Date 2/28/2013 - Test Strip Lot # 18005M; Kit Lot # P210191 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X009M Kit Lot # P210192 - Kit Expiration Date 4/30/2013 - Test Strip Lot # 1X010M; Kit Lot # P217033 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y011M; Kit Lot # P217034 - Kit Expiration Date 5/31/2013 - Test Strip Lot # 1Y012M; Kit Lot # P217035 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M; Kit Lot # P222808 - Kit Expiration Date 6/30/2013 - Test Strip Lot # 1Z013M.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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