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DATE RECALL INITIATED: September 20, 2004 LOT NUMBER / EXPIRATION DATE : HBK133     12/17/2004 MANUFACTURER: Ortho Clinical Diagnostics Raritan, New Jersey REASON: Ortho-Clinical Diagnostics, Inc. has confirmed complaints of positive control failures when using ORTHO Antibody to HBsAg ELISA Test System 3. This is due to low Optical Density (OD) values, less than 0.225, for the positive control, resulting in invalid plates. Customers have been asked to contact the manufacturer to arrange for product return. 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.

Updated October 26, 2004

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