Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
Publicado el 2 de agosto de 2017 · Inicio del retiro: 19 de mayo de 2017
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
An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ¿g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Fisher Diagnostics
- Distribuidor
- USA (nationwide) including Puerto Rico, and Internationally to Colombia
- Lote
- Lot Number 948546, Exp. 9/30/2017
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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