Events

Recall of Device Recall Access Immunoassay Systems Hybritech free PSA Calibrator

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
    48960
  • Event Risk Class
    Class 2
  • Event Number
    Z-2220-2009
  • Event Initiated Date
    2008-01-08
  • Event Date Posted
    2009-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72407
  • 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
    Test,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign condit - Product Code MTG
  • Reason
    Beckman coulter incorrectly shipped access hybritech free psa calibrators containing dual calibration cards (hybritech and who) to your lab. the who calibration for free psa is marketed without a pma.
  • Action
    Beckman Coulter contacted customers by phone beginning January 11, 2009 and sending a Product Corrective Action letter informing them to discontinue use and discard the referenced product immediately. For further information, contact Customer Technical Support at 1-800-854-3633 or contact your local Beckman Coulter Representative.

Device

Device Recall Access Immunoassay Systems Hybritech free PSA Calibrator
  • Model / Serial
    Part Number: 37215, Lot Number: 715293.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA.
  • Product Description
    Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. || The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (PSA) in human serum using the Access Immunoassay System.
  • Manufacturer
    Beckman Coulter Inc

Manufacturer

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