Events

Recall of VerifyNow

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
    33691
  • Event Risk Class
    Class 3
  • Event Number
    Z-0102-06
  • Event Initiated Date
    2005-09-13
  • Event Date Posted
    2005-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-03-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42291
  • 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
    In 2001, separate reports of mild shock, sparking and smoke from accumetrics pn 29001 power supply.
  • Action
    Letters and replacement power supplies were sent to consignees by Fedex, 2-day with proof of delivery. End-user customers were instructed to return the affected power supply to Accumetrics, using the provided pre-paid shipping carton. Consignees who do not return the power supply within two weeks of the notification will be contacted by phone to assess compliance with the recall and to determine the status of the product at the site.

Device

VerifyNow
  • Model / Serial
    lot number G-13850
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    CA, FL, IL, LA, NH, NV, NY, OK, WA
  • Product Description
    Accumetrics part number 29001 VerifyNow Instrument, printe power supply
  • Manufacturer
    Accumetrics Inc

Manufacturer

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