BEUDAMED
    FDA Recall Terminated

    Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.

    Recall: Z-2733-2015 · Initiated July 28, 2015

    Recall

    Recall Number
    Z-2733-2015
    Event Number
    71878
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    MSW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 28, 2015
    Posted
    September 3, 2015
    Terminated
    April 13, 2016
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.

    Reason

    Beckman Coulter, Inc. is recalling Access Thyroglobulin reagent packs because some may exhibit greater than 10% imprecision at concentrations <10 ng/mL.

    Action

    On 07/28/2015 the firm sent out customer notification letters via first class mail and e-mail. The firm's letter contained the following instructions: 1. Discard all Access Thyroglobulin reagent pack lots listed in the letter. 2. Evaluate Access Thyroglobulin results <10 ng/mL when using the reagent pack lot numbers listed to determine if controls and/or patients were higher than expected or did not match the clinical status of the patient. 3. At the discretion of the Laboratory Director, notify clinicians that it is possible the Access Thyroglobulin sample results reported by the laboratory were affected by this issue. The firm's notification letter requests that the information be shared with laboratory staff. If any affected products have been forwarded provide a copy of the letter to them. The firm requests that customers complete and return the Response Form within 10 days. Any questions contact the Customer Care Center: 1. From website at http://www.beckmancoulter.com 2. By phone: call 1-800-854-3633 in the United States and Canada. 3. Outside the United States and Canada, contact local Beckman Coulter representative

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Algeria, Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Lithuania, Mexico, Morocco, New Zealand, Oman, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam and Yemen.

    Quantity

    3,035 (U.S.) and 7,123 (International)