FDAFDA · Alimentos y medicamentos·N.º oficial Z-2237-2012
i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
Publicado el 29 de agosto de 2012 · Inicio del retiro: 7 de marzo 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
Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include additional information regarding user documentation.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Abbott Point Of Care Inc.
- Distribuidor
- Worldwide Distribution - US Nationwide, International
- Lote
- 510(K)K031739 List Number 06F15-03, 06F15-04, 03P90-25, 600-9009-25 All lots
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States