Events

Recall of Access Immunoassay Systems Assay Protocol: Dil-AFP.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Beckman Coulter 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
    32748
  • Event Risk Class
    Class 2
  • Event Number
    Z-1388-05
  • Event Initiated Date
    2005-07-18
  • Event Date Posted
    2005-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40748
  • 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
    Kit, Test,Alpha-Fetoprotein For Testicular Cancer - Product Code LOJ
  • Reason
    Pipetting for dil-alpha-fetoprotein when performed on the access, access 2 and synchron lx i 725 has a potential to create splashing which may cause erroneous results.
  • Action
    Letters to customers were sent July 18, 2005. Firm will upgrade software later in the year. Customers are advised to not perform the automated dilution protocol but refer to the method in the directions.

Device

Access Immunoassay Systems Assay Protocol: Dil-AFP.

Manufacturer

Beckman Coulter Inc
  • Manufacturer Address
    Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
  • Source
    USFDA