bioMerieux is recalling NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic extraction reagents due to potential inaccurate test results.
The class I recall is a continuation to the firm’s previous recall of NucliSENS easyMAG Magnetic Silica.
NucliSENS reagents and accessory products have been recalled due to a quality problem of the magnetic silica (MagSil) component.
Kits with the affected lots of the magnetic silica cannot fully extract nucleic acids from the sample and detect infection or provide proper diagnosis.
The detection problem may lead to a risk of false negative results, invalid results, or under-quantification for clinical laboratory tests.
NucliSENS easyMAG Magnetic Silica is intended to extract nucleic acids, including RNA or DNA, which contain genetic material from biological samples, such as blood and tissue.
These can be used for different applications for molecular infectious disease assays, molecular oncology assays, and molecular genetics assays.
NucliSENS Magnetic Extraction Reagents are accessory products, which will be used with the NucliSENS miniMAG, eMAG, and easyMAG systems. These products allow the automated extraction of RNA/DNA from biological samples.
Health care professionals will use these products in vitro diagnostic applications. MagSil can be used to extract and purify genetic material from patient samples.
Through its subsidiaries, bioMerieux produces diagnostic solutions such as reagents, instruments and software solutions to its customers in around 150 countries.