Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Vaccines, Blood & Biologics

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.

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 06/27/2013
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.