BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1645-2012 · Initiated October 11, 2011

    Recall

    Recall Number
    Z-1645-2012
    Event Number
    61770
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    MTG
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    October 11, 2011
    Posted
    May 22, 2012
    Terminated
    March 18, 2013
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    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.

    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

    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.

    Quantity

    90,965 units total (24,951 units in US)