MagSIL (Nuclisense easyMAG magnetic Silica) was found to not perform to standards during certain testing procedures.
On Jan. 13, the FDA issued a Class 1 recall—the most serious type of recall—of magnetic silica (known as MagSil in the industry) because the test, used to isolate genetic materials, wasn’t performing according to standards in certain testing and research applications.
NucliSENS easyMAG Magnetic Silica (MagSIL) is used to extract nucleic acids (RNA or DNA) from biological samples, such as blood and tissue, which could then be used in various applications for research on molecular infectious diseases, molecular oncology, and molecular genetics.
Manufacturer bioMerieux chose to initiate a recall of the MagSIL because of the way the material affects the nucleic acids it is supposed to extract and purify. However, kits outfitted with the affected lots of magnetic silica have shown poor performance in certain testing settings and applications. This problem could create false-positive results for clinical and laboratory testing.
Laboratories, healthcare providers, and patients are all considered to be effected by the recall. So far, over 3700 units of the MagSIL product have been recalled, starting with batches distributed in January of 2016. The FDA is recommending that all test results generated by the recalled magnetic silica should be reviewed to determine if additional actions are needed.
For more information, you can reach bioMerieux Clinical Customer Service at (800) 682-2666 or bioMerieux Industry Customer Service at (800) 634-7656. For additional information on the FDA’s recall of the product, please visit their website.