FDAFDA · Alimentos y medicamentos·N.º oficial Z-2460-2012
Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.
Publicado el 3 de octubre de 2012 · Inicio del retiro: 12 de julio de 2012
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
Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Alere San Diego, Inc.
- Distribuidor
- Nationwide Distribution.
- Lote
- Lot Codes: K51245RB, W51022RB, W51207RB
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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