Events

Recall of VerifyNow P2Y12 Assay Device Kit

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
    36707
  • Event Risk Class
    Class 2
  • Event Number
    Z-0228-2007
  • Event Initiated Date
    2006-09-05
  • Event Date Posted
    2006-12-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49194
  • 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
    Platelet assay, automated - Product Code JOZ
  • Reason
    The verifynow p2y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.
  • Action
    The 333 consignees were notified by regular mail or by E-mail on 9/5/2006 -- 9/13/2006. There were four versions of the notification letter tailored to (1) domestic customers; (2) domestic distributors; (3) international customers; and (4) international distributors. Each notification was accompanied by a 'fax back' form which customers were asked to sign and return to Accumetrics as an acknowledgement they received the notification letter. The notification letter instructs consignees that test results with the VerifyNow P2Y12 Assay and all VerifyNow assays should be interpreted in conjunction with other clinical and laboratory data available to the clinician. Caution is advised when testing patients outside the ranges documented in the package insert.

Device

VerifyNow P2Y12 Assay Device Kit
  • Model / Serial
    Lot Numbers: WK0002A , WK0003A, WK0003B, WK0004A ,   WK0005A , WK0006A, WK0006AR, WK0006B, WK0006BR,   WK0007A, WK0008A, WK0009A, WK0010A ,WK0010B, 10WK000C, WK0011A, WK0012A and WK0013A
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution- USA, and countries of Australia, Canada, France, Germany, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Spain, Sweden, Switzerland, & United Kingdom
  • Product Description
    VerifyNow P2Y12 Assay Device Kit, Part Number 85054
  • Manufacturer
    Accumetrics Inc

Manufacturer

Accumetrics Inc
  • Manufacturer Address
    Accumetrics Inc, 3985 B Sorrento Valley Blvd, San Diego CA 92121
  • Source
    USFDA