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

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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.

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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 22, 2004
 
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