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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Urgent Product Correction - Bio-Rad Laboratories Multispot HIV-1/HIV-2 Rapid Test - Bio-Rad Laboratories

DATE NOTIFICATION INITIATED:

June 6, 2008

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Bio-Rad Laboratories Multispot HIV-1/HIV-2 Rapid Test

Catalog Number 25228

Lot Number Expiration Date
949779 7/30/08
950636 9/18/08
950988 10/12/08
952077 11/29/08
952635 1/3/09
953287 1/30/09

MANUFACTURER:

Bio-Rad Laboratories
Redmond, Washington

REASON:

The package insert provided with the above listed lots contains a typographical insert. The affected package insert is identified by the "Revised: May 2007" and "506097" information found on the back page of the insert. The typographical error will be corrected for future shipments of Multispot.

 

Contact FDA

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

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448
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