Device Recall ACE EZA1c Reagent, Glycosylated hemoglobin assay.

  • Modelo / Serial
    EZA1c Reagent ACI-30, Lot # F2481, Exp. 9/2008 and EZA1c Reagent ACI-30, Lot # F2603, Exp 01/2009. The following EZA1c control and calibrator kits were included in the customer notification instructing them to discard the product. There is no use for these products without the reagent. (EZA1c Controls C2-82, Lot # HBC00507-1, Exp. 10/2008 and EZA1c Calibrators S2-82, Lot # HBS00907-1, Exp. 10/2008).
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. || Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c) Assay. For in vitro diagnostic use only. || Alfa Wassermann Diagnostic Technologies, LLC., || 4 Henderson Drive, || West Caldwell, NJ 07006. || ACE EZA1c Reagent is intended for the quantitative determination of stable hemoglobin A1c in human whole blood samples using the ACE and Ace Alera clinical chemistry systems. Measurement of hemoglobin A1c is a viable indicator for long-term diabetic control.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Alfa Wassermann, Inc., 4 Henderson Dr, Caldwell NJ 07006-6608
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA