Product Correction
Hepatitis B Surface Antigen AUSAB EIA
DATE NOTIFICATION INITIATED:
April 21, 2008
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Hepatitis B Surface Antigen AUSAB EIA
List Number: 9006-24
Lot Number: 59238M200
Expiration: June 11, 2008
MANUFACTURER:
Abbott Laboratories
Abbott Park, IL
REASON:
Abbott has determined that this lot of AUSAB EIA has reduced sensitivity using Procedure A incubation method. Recent product stability data indicate that our internal low-level anti-HBs panel member (15mIU/mL) may produce non-reactive results when tested with this lot.
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.