DATE RECALL INITIATED:
May 17, 2004
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.