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BioMerieux SA recalls NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used wit
Recalled August 17, 2016 · FDA recall Z-2342-2016 · BioMerieux SA
Hazard
Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform. · FDA Class I
Units
7,845 units
Sold at
Worldwide Distribution - US Nationwide in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MO, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, and the countries of Angola, Argentina, Austria, Australia, Austria, Botswana, Brazil, Burkina Faso, Cambodia, China, Colombia, Djibouti Antilles, Estonia, Georgia, Germany, Greece, India, Israel, Italy, Kuwait, Latvia, Malaysia, Mexico, Netherlands, Poland, Qatar, Russia, Senegal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Zambia, and Zimbabwe
Description
Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
Product
NucliSENS easyMAG Magnetic Silica The NucliSENS easyMAG accessory products are reagents and disposable to be used with the bioMerieux extraction systems which mention these products in their User Manuals. They enable the automated extraction (purification and concentration) of total nucleic acids (RNA/DNA) from biological samples which are liquid and homogeneous. These products are intended for in vitro diagnostic use by healthcare professionals only.
Manufacturer(s)
BioMerieux SA
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →