BEUDAMED
    FDA Recall Terminated

    Angiotensin I [125I] Radioimmunoassay Kit, 500 Tube Catalog Number: NEA105 For in-vitro diagnostic use

    Recall: Z-1207-03 · Initiated July 28, 2003

    Recall

    Recall Number
    Z-1207-03
    Event Number
    26852
    Firm
    Perkinelmer Life Sciences, Inc.
    FEI Number
    1000513616
    Product Code
    CIB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2003
    Posted
    September 12, 2003
    Terminated
    November 19, 2003
    Address
    549 Albany Street, Boston, MA, 02118

    Description

    Angiotensin I [125I] Radioimmunoassay Kit, 500 Tube Catalog Number: NEA105 For in-vitro diagnostic use

    Reason

    Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples

    Action

    PerkinElmer notified all customers who received the lots by telephone by July 23, 2003 followed by letter dated July 25, 2003, which includes instructions for documenting receipt and lot removal either by destroying or returning product to PerkinElmer

    Distribution

    MD, NC, CA, VT, IL, MI, IL, NY, DC, MN, HI, WA, UT Nationwide. International: Belgium, Germany, Israel, UK, Canada, Hugary, Switzerland, Korea

    Quantity

    48 Kits