Events

Rappel de Device Recall VerifyNow IIb/IIIa Test, 10Test Kit

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Accumetrics Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66834
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0482-2014
  • Date de mise en oeuvre de l'événement
    2013-11-14
  • Date de publication de l'événement
    2013-12-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-12-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123688
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, automated platelet aggregation - Product Code JOZ
  • Cause
    Accumetrics is recalling the verifynow iib/iiia 10-test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. the correct instruction is to perform the test within 15 minutes of collecting the patient sample.
  • Action
    Accumetrics sent an Urgent Medical Device Correction letter dated November 14, 2013 to end users for the VerifyNow IIb/IIIa 10-Test. The letter informs the customers of the problems identified and the actions to be taken. The customers are instructed to call Accumetrics Customer Support at (800) 643-1640 option 2 or email at support@accumetrics.com. Customers are instructed to complete and return the enclosed Customer Account Tracking Form as soon as possible. For questions regarding this recall call 858-643-1600.

Device

Device Recall VerifyNow IIb/IIIa Test, 10Test Kit
  • Modèle / numéro de série
    Lot No. WC0181H, WC0181J, WC0181K
  • Classification du dispositif
    Hematology and Pathology Devices
  • 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
    Accumetrics Inc

Manufacturer

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