FDAFDA · Alimentos y medicamentos·N.º oficial Z-1903-2012
PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample
Publicado el 4 de julio de 2012 · Inicio del retiro: 15 de mayo 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
During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Polymer Technology Systems, Inc.
- Distribuidor
- Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.
- Lote
- Cat No. 1720; and Lot number F103
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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