FDAFDA · Alimentos y medicamentos·N.º oficial Z-1727-2014
Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. . The Alere Triage¿ D-Dimer test is intended for use as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Publicado el 18 de junio de 2014 · Inicio del retiro: 2 de mayo de 2014
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 initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Alere San Diego, Inc.
- Distribuidor
- Nationwide Distribution only.
- Lote
- PN 98100, Lot W53884B.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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