BEUDAMED
    FDA Recall Terminated

    IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA

    Recall: Z-0501-2007 · Initiated August 11, 2006

    Recall

    Recall Number
    Z-0501-2007
    Event Number
    37002
    Firm
    Abbott Laboratories MPG
    FEI Number
    1415939
    Product Code
    NRP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 11, 2006
    Posted
    February 15, 2007
    Terminated
    January 18, 2008
    Address
    100 Abbott Park Rd, Abbott Park, IL, 60064-3502

    Description

    IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA

    Reason

    The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens.

    Action

    Abbott initiated a field correction recall by letter dated 8/11/06 to all customers receiving the affected reagent. The accounts were informed of the shift in sample values after storage at 2-8*C or with freeze thaw of specimens with the affected lots of reagents. The accounts were requested to review the revised sample handling information included in the attachment to the letter with their laboratory personnel and retain a copy of the letter and attachment for their records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.

    Distribution

    Worldwide, including USA, Puerto Rico, Poland, Croatia, Latvia, Estonia, Serbia & Montenegro, Japan, Turkey, Singapore, China, India, Taiwan, Thailand, South Africa, South Korea, Australia, New Zealand, Norway, Italy, Portugal, Spain, Greece, Panama, Hungary, Slovakia, Russia, Romania, Cyprus, Germany, Lithuania, Saudi Arabia, Jordan, Israel, Lebanon, Kuwait, Oman, Qatar, UAE, Egypt, Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Argentina, Brazil, El Salvador, Canada, Ireland, United Kingdom, Sweden, Netherlands, Belgium, France, Austria, Czech Republic, and Switzerland

    Quantity

    2,800 kits