Events

Recall of Access Hybritech Free PSA

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
    61770
  • Event Risk Class
    Class 3
  • Event Number
    Z-1645-2012
  • Event Initiated Date
    2011-10-11
  • Event Date Posted
    2012-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109024
  • 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
    A recall was initiated because beckman coulter has confirmed a change to the recommended diluents for the access hybritech free psa reagent.
  • Action
    Beckman Coulter sent a Product Correction letter dated October 11, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed regarding a change to the recommended diluents for the Access Hybritech free PSA reagent. Patient safety is not affected by this change. " Do not dilute elevated free PSA patient samples with Wash Buffer II. " Do not dilute elevated free PSA patient samples using the UniCel DxI onboard dilution feature. " Dilute elevated free PSA samples with Access Hybritech free PSA Calibrator S0 only. " A review of historical patient results is not required because there is no effect on clinical interpretation. * The UniCel DxI onboard dilution feature is only available in limited geographies. " An updated version of the UniCel DxI Assay Protocol File (APF) will remove the Access Hybritech free PSA (dfPSA) onboard dilution assay from the list of available assays. " The Access Hybritech free PSA IFU will be updated to remove Wash Buffer II as an acceptable diluent for elevated patient samples. Correct any procedure manuals or other documents created in your laboratory that list Wash Buffer II as an acceptable diluent for the Access Hybritech free PSA assay. Please share this information with your laboratory staff. If you have forwarded any of the affected product listed above to another laboratory, please provide a copy of the letter to them. Please complete and return the enclosed response form within 10 days so we are certain you received this important communication. If you have any questions regarding this notification, please contact our Customer Support Center " Via our website, http://www.beckmancoulter.com/customersupport/support " Via phone, call 1-800-854-3633 in the United States and Canada Outside the United States and Canada, contact your local Beckman Coulter Representative. We apologize for the inconvenie

Device

Access Hybritech Free PSA
  • Model / Serial
    All lots
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide ) and the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia, Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, French, Polynesia, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libyan, Arab, Jamahiriya, Macao, Mexico, Moldova, Republic of Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Panama, Philippines, Poland, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab, Emirates, United Kingdom, Uruguay ,Venezuela, Viet Nam, Yemen and Zimbabwe.
  • Product Description
    Access Hybritech Free PSA, Part Number: 37210 || Free PSA is used to aid in the differentiation between prostate cancer and benign prostatic conditions when total PSA levels are between 4 and 10 ng/mL.
  • Manufacturer
    Beckman Coulter Inc.

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA