Events

Recall of Access

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
    37065
  • Event Risk Class
    Class 2
  • Event Number
    Z-0417-2007
  • Event Initiated Date
    2006-10-26
  • Event Date Posted
    2007-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49841
  • 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
    in vitro diagnostic - Product Code DDC
  • Reason
    Low end imprecision affecting both s0 calibrators and patient samples which can lead to inaccurate low level patient results when using the access thyroglobulin antibody assay.
  • Action
    A Product Corrective Action (PCA) letter was mailed on Oct 27, 2006 to all Thyroglobulin Antibody customers. They are informed that there has been an increase in customer feedback regarding low end imprecision affecting both S0 calibrators and patient samples, which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. The letter informs the customer that the firm recommends that they use an alternate method for testing TgAb. (Letter was sent by US mail). Customers are asked to complete and return the enclosed response form within 10 days.

Device

Access
  • Model / Serial
    518729 (expires 10/31/06); 520617 (expires 12/31/06); 612764 (expires 12/31/06); 613481 (expires 3/31/07); 614541 (expires 5/31/07); 616787 (expires 8/31/07)
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Access¿ Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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