January 31, 2017 at 9:30 am #2938
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents
- Lot Numbers: See List Below
- Distribution Dates: May 03, 2016 to August 18. 2016
- Devices Recalled in the U.S.: 376
The NucliSENS easyMAG Magnetic Silica is used to extract nucleic acids (RNA or DNA) which contain genetic material from biological samples, such as blood, tissue, etc., which could then be used in various applications for molecular infectious disease assays, molecular oncology assays, and molecular genetics assays.
The NucliSENS Magnetic Extraction Reagents are accessory products to be used with the NucliSENS miniMAG, eMAG, and easyMAG systems. These products enable the automated extraction of RNA/DNA from biological samples. These products are intended for in vitro diagnostic use by health care professionals.
Reason for Recall
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.