Device Recall STA System Control NP

  • Modèle / numéro de série
    K9483518 D029396 Lot #106775
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution and USA (Nationwide) and including Canada
  • Description du dispositif
    STA - System Control N + P || Product Usage: || The STA¿ -System Control N+P kit provides a normal plasma and an abnormal plasma intended for use as two control levels for the following assays performed on analyzers of the STA¿brand name suitable to these reagents: -the Reagent 1 (STA¿-System Control N)is for the following tests: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Clauss method), thrombin time (TT), Reptilase¿¿ time, factors II, V, VII, VIII, IX, X, XI and XII, antithrombin (AT), protein C, protein S, plasminogen and antiplasmin. -the Reagent 2 (STA¿¿ -System Control P) is for the tests as described above except thrombin time (TT) and Reptilase¿¿ time. Do not use the STA¿¿ -System Control N+P kit on STA Satellite¿ for the control of the APTT performed with the STA¿¿-rTT kit.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Diagnostica Stago, Inc., 5 Century Dr, Parsippany NJ 07054-4607
  • Source
    USFDA