DATE NOTIFICATION INITIATED:
PRODUCT / LOT NUMBER
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.
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.