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BioMerieux Recalls Molecular Assay Reagents

NEW YORK (GenomeWeb) – BioMérieux is recalling two extraction reagents used in molecular assays due to quality problems, the US Food and Drug Administration said on Friday.

The products covered by the recall are the NucliSens easyMag Magnetic Silica and NucliSens Magnetic Extraction Reagents. The recall of the NucliSens easyMag product is the continuation of a previous recall by BioMérieux during the summer. The firm is recalling the NucliSens Magnetic Extraction Reagents after it determined the product to be in the scope of the previous recall, the FDA said.

The NucliSens reagents and accessory products are being recalled due to problems in the magnetic silica component. Kits with the affected lots of the component may not be able to fully extract nucleic acids from samples and detect infection or provide a correct diagnosis. As a result, assays using the magnetic silica may give false negatives, invalid results, or underquantification for clinical laboratory results, leading to inappropriate treatment and other health risks, the FDA said.

The NucliSens easyMag product is used for extracting nucleic acids from biological samples. The NucliSens Magnetic Extraction Reagents are an accessory product that enables the automated extraction of RNA/DNA from biological samples.

BioMérieux sent letters to affected customers in November alerting them to the problem, the FDA said.