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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Important Product Information - Correction - Corzyme-Abbott Laboratories

DATE NOTIFICATION INITIATED:

 

February 18, 2005

PRODUCT / LOT NUMBER

List Number 9977
All Lots

 

MANUFACTURER:

 

Abbott Laboratories
Abbott Park, IL

REASON:

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.

 

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

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Food and Drug Administration

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Rockville, MD 20852-1448