Devices

Device Recall VerifyNow IIb/IIIa Test

  • Model / Serial
    Lot/Serial No.  WC0182B, WC0182C, WC0182A, WC0182D, WC0182E, WC0182F, WC0182G, WC0180C, WC0180E, WC0180F, WC0181A, WC0181C, WC0181D, WC0181F, WC0180A, WC0180B, WC0180D, WC0181B, WC0181E, WC0181G, WC0181H, WC0181J, WC0181K.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution
  • Product Description
    VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. || Product Usage: || 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 IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
  • Manufacturer
    Accumetrics Inc
  • 1 Event

Manufacturer

Accumetrics Inc
  • Manufacturer Address
    Accumetrics Inc, 3985 Sorrento Valley Blvd Ste B, San Diego CA 92121-1497
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall VerifyNow IIb/IIIa Test, 10Test Kit
  • Model / Serial
    Lot No. WC0181H, WC0181J, WC0181K
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
  • Product Description
    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
    Accumetrics Inc