Events

Recall of Device Recall Beckman Coulter Expo 32 ADC

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
    36958
  • Event Risk Class
    Class 2
  • Event Number
    Z-0471-2007
  • Event Initiated Date
    2006-11-01
  • Event Date Posted
    2007-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49668
  • 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
    Flow Cytometers - Product Code JQP
  • Reason
    The firm has confirmed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the parameter selection dialog box is accessed. this issue is limited to only protocols utilizing the ratio parameter.
  • Action
    A Product corrective Action (PCA) letter was mailed on 11/1/06 to Expo 32 software accounts. They are informed that the ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialogue box is accessed. The issue is limited to only protocols utilizing the Ratio parameter. An immediate user preventive action to remedy this issue each time acquisition of samples that require a protocol utilizing the ratio parameter is desired is given within the letter: 1) Perform acquisition of samples in batches which use protocols containing the same ratio parameter assignments. 2) Before running samples, open the protocol intended for use and open the Parameter Selection dialog box to ensure the correct ratio parameter assignments for numerator and denominator are selected. Make any necessary changes and save the protocol. 3) Run samples. (Letter was sent by US mail). A response form is included.

Device

Device Recall Beckman Coulter Expo 32 ADC
  • Model / Serial
    all codes with the Software version
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide including the states of MA, AL, CO, MI, IN, MD, MO NY, PA, TX, AR, CA, NJ, FL, and TN
  • Product Description
    Expo32 ADC Software Version 1.1C, Part Number 6418337-New Users Software Kit, and Part Number 175454 Upgrade Software Kit used with the Coulter EPICS XL Flow Cytometers
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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