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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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


DATE NOTIFICATION INITIATED: October 18, 2012
 
PRODUCT / LOT NUMBER:
 
Bio-Rad Multispot HIV-1/HIV-2 Rapid Test
Catalog Number 25228, Lot number 114284
 
MANUFACTURER:
 
Bio-Rad
Redmond, Washington
 
REASON:
 
Bio-Rad Laboratories has received reports of decreased reactivity accompanied by a faint speckling appearance on cartridge membranes when using some vials of Conjugate in the Multispot HIV-1/HIV-2 Rapid Test, kit lot number 114284. Our internal investigation has verified that some Conjugate vials contained in this kit lot (Conjugate lot 114280) can produce reactions of reduced intensity accompanied by a faint speckling appearance on cartridge membranes. Customers are asked to refer to the Urgent Product Correction Notification demonstrating the appearance of “Normal” and “Abnormal” results. 
 

 
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.