Events

Recall of VerifyNow Asprin Assay Kit || Part No. 85034

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
    29165
  • Event Risk Class
    Class 2
  • Event Number
    Z-1018-04
  • Event Initiated Date
    2004-05-10
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33241
  • 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
    Test results too low in control.
  • Action
    Letters were sent FEDEX on May 10, 2004. Customers were requested to discard the product. Distributors opted to return product. A response form was included to track materials.

Device

VerifyNow Asprin Assay Kit || Part No. 85034
  • Model / Serial
    Assay Device Lot WD0034, Kit Lots W17105, W17140.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    VerifyNow Asprin Assay Kit || Part No. 85034
  • Manufacturer
    Accumetrics Inc

Manufacturer

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