Events

Recall of Device Recall VerifyNow IIb/IIIa Test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Accumetrics Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67508
  • Event Risk Class
    Class 2
  • Event Number
    Z-1172-2014
  • Event Initiated Date
    2014-02-13
  • Event Date Posted
    2014-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125633
  • Notes / Alerts
    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.
  • Extra notes in the data
    System, automated platelet aggregation - Product Code JOZ
  • Reason
    Accumetrics is recalling the verifynow iib/iiia test because it may result in the reporting of an erroneous low platelet aggregation unit (pau) result. an erroneous low pau result may cause a low percent inhibition calculation or low baseline pau.
  • Action
    Accumetrics sent an Urgent Medical Device Recall letter dated February 13, 2014 to all affected customers. The recall letter informs the customers of the problems identified and the actions to be taken. Cusotomers are instructed to complete the attached Customer Account Tracking Form and return it within 10 days by fax, email or mail. Customers with questions are instructed call Accumetrics Customer Support at (800) 643-1640 option 2 or email at support@accumetrics.com.

Device

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

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