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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of NucliSens Automated Isolation Reagents for Use with NucliSens HIV-1 QT - bioMerieux bv

DATE RECALL INITIATED:

May 17, 2004

 

LOT NUMBER:

 

04031904

 

MANUFACTURER:

bioMerieux bv
Boxtel, Netherlands

 

DISTRIBUTOR

bioMerieux, Inc
Durham, NC

 

REASON:

 

The recalled reagent is used in the automated isolation of nucleic acids from lysed biological samples. Samples isolated with the recalled product are further tested with an assay, such as the NucliSens HIV QT quantitative viral load assay. Some components of the NucliSens Automated Isolation reagents contain the raw material guanidine isothiocyanate (GuSCN). Some irregularities have been observed with one lot of this raw material, which may affect the sensitivity and accuracy of assays, such as the NucliSens HIV QT.

 

 

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