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Vaccines, Blood & Biologics

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


May 17, 2004







bioMerieux bv
Boxtel, Netherlands



bioMerieux, Inc
Durham, NC




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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