BEUDAMED
    FDA Recall Terminated

    Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.

    Recall: Z-2227-2012 · Initiated October 11, 2011

    Recall

    Recall Number
    Z-2227-2012
    Event Number
    62791
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    CDP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 11, 2011
    Posted
    August 20, 2012
    Terminated
    March 14, 2013
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.

    Reason

    A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0.

    Action

    Beckman Coulter sent a Product Correction letter dated October 11, 2011, to all affected customers. The PCA letter informed the customers of the problem identified and the actions to be taken. Customers were informed to stop SDA usage as an alternative dilutent and that the S0 dilutent is to be used for manual dilution of the patient sample for Total T3. They will also be informed to no longer use the On Board Dilution (OBD) option for Total T3. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions regarding this notification were instructed to contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-961-4941.

    Distribution

    Worldwide Distribution - USA (nationwide), Canada, and internationally.

    Quantity

    117,385 units total (33,918 units in US)