Device Recall ACE AST Reagent Kits

  • Modelo / Serial
    ACE¿ AST Reagent Product reorder numbers SA1047 (Lot F3609) and RX1047 (Lot F3610)
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. || Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE¿, ACE Alera¿ and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories.
  • Manufacturer
  • 1 Event

Fabricante

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