Events

Recall of Device Recall VERIFYNOWP2Y12 ASSAY

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
    61761
  • Event Risk Class
    Class 2
  • Event Number
    Z-1854-2012
  • Event Initiated Date
    2012-02-06
  • Event Date Posted
    2012-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109704
  • 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
    The recall was initiated by accumetrics because of a field correction to the verifynow system; specifically the results reported when running the verifynow p2y12 test. currently the verifynow p2y12 test reports three values: pru, base and % inhibition. the change implemented is the elimination of the base and % inhibition results. there will be no change to the reporting of the pru result whic.
  • Action
    Accumetrics, Inc. sent an Urgent Field Correction notification letter and an Ackknowledgement - fax back form to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter informed customers that an Accumetrics representative will be contacting them to schedule an appointment to update their VerifyNow instrument software. The letter stated that Accumetrics realizes that procedures and report format may need to be revised as software changes is implemented, and will provide assistance to help in making this transition. For any questions or concerns, call at 1-800-643-1640 ext. 2; or email at: support@accumetrics.com.

Device

Device Recall VERIFYNOWP2Y12 ASSAY
  • Model / Serial
    Not available
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    VerifyNow System, part #85005-6H || Product Usage: || The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
  • 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