Device Recall VerifyNow IIb/IIIa Test, 10Test Kit

  • Modèle / numéro de série
    Lot No. WC0181H, WC0181J, WC0181K
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
  • Description du dispositif
    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.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Accumetrics Inc, 3985 Sorrento Valley Blvd Ste B, San Diego CA 92121-1497
  • Société-mère du fabricant (2017)
  • Source
    USFDA