FDAFDA · Alimentos y medicamentos·N.º oficial Z-2034-2012
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system
Publicado el 25 de julio de 2012 · Inicio del retiro: 28 de junio de 2011
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
Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Epocal Inc
- Distribuidor
- US nationwide Distribution in the state of CA.
- Lote
- Catalog #CT-1004-00-00, lot number 07-11087-00
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Canada
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