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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 NumberExpiration Date
9497797/30/08
9506369/18/08
95098810/12/08
95207711/29/08
9526351/3/09
9532871/30/09

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
(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