FDAFDA · Alimentos y medicamentos·N.º oficial Z-0482-2014
VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.
Publicado el 18 de diciembre de 2013 · Inicio del retiro: 14 de noviembre de 2013
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
Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The correct instruction is to perform the test within 15 minutes of collecting the patient sample.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Accumetrics Inc
- Distribuidor
- Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
- Lote
- Lot No. WC0181H, WC0181J, WC0181K
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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