Urgent Product Correction

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

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.


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.

 
Updated: June 30, 2008