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Important Product Information - Correction
Corzyme, Abbott Laboratories

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    February 18, 2005


    List Number 9977
    All Lots


    Abbott Laboratories
    Abbott Park, IL


    Abbott Laboratories recently completed a study comparing an internally produced anti-HBc dilution panel (Panel) used in product testing against a reference serum provided by the Paul-Erhlich-Institut (PEI, Germany). This Panel is used to determine the CORZYME Positive Control anti-HBc concentration expressed in PEI Units/mL. The results of the study revealed differences in PEI Units/mL of the anti-HBc dilution panel as compared to a reference serum from the Paul Erhlich-Institut. As a result of this difference, concentrations expressed in PEI Units/mL are inaccurate.

    The CORZYME Positive Control Human anti-HBc concentration in PEI Units/mL will no longer be provided. In addition, the PEI reference range statement in the CORZYME Package Insert (66-6633/R17) will be removed in the next revision of the CORZYME Package Insert. Consignees have been asked to place a copy of their "Important Product Information Letter" with any remaining CORZYME kit inventory.

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.


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