Medical Device Safety and Recalls: bioMerieux Recalls NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents due to Potential Inaccurate Test Results

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: bioMerieux Recalls NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents due to Potential Inaccurate Test Results

This is a continuation of bioMerieux's previous recall for NucliSENS easyMAG Magnetic Silica. The firm has identified additional affected product lots, and an additional product, the NucliSENS Magnetic Extraction Reagents, which have been determined to be in scope of the previous recall.

bioMerieux is recalling the NucliSENS reagents and accessory products due to a quality problem of the magnetic silica (MagSil) component. MagSil is used to extract and purify genetic material from patient samples. Kits with the affected lots of the magnetic silica may not be able to fully extract nucleic acids from the sample and detect infection or provide proper diagnosis. The detection problem could lead to a risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment. The use of the affected product may cause serious adverse health consequences, including death.

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