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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Product Correction: Hepatitis B Surface Antigen AUSAB EIA-Abbott Laboratories

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.

 

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Food and Drug Administration

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Rockville, MD 20852-1448
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