Device Recall Remel Spectra MRSA

  • Modelo / Serial
    Cat. # R01821 (10 pack) - Lot 028251, exp. 2011.06.13;  Cat. #R01822 (100 pack) - Lot 028252, exp. 2011.06.13; 028883, exp. 2011.06.14; 028884, exp. 2011.06.14; and 031922, exp. 2011.06.21
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution--including Puerto Rico.
  • Descripción del producto
    Remel Spectra MRSA, Ref R01821, 10 plates per package, and Ref R01822, 100 plates per package. The firm name on the label is Remel, Lenexa, KS. || The product is a selective and differential chromogenic medium recommended for use in the qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA in healthcare settings. It is also intended for use in the qualitative detection of MRSA from positive blood cultures demonstrating gram-positive cocci on Gram stain.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA