Device 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.
Z-2342-2016
Product summary
- Firm
- BioMerieux SA
- Event
- Event 74761
- Status
- Terminated
- Classification
- Class I
- Quantity
- 7,845 units
- Official record key
device-enforcement:Z-2342-2016
Official wording
Reason: Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.
Code information: Lots - Z017BB1MS, Z017BF1MS, Z017CA1MS, Z017BE1MS, Z017CC1MS, Z017CD1MS, Z017CH1MS, Z017BD1MS, Z017DB1MS, Z017BA1MS, Z017CF1MS, Z017CE1MS, Z017CG1MS, Z017DA1MS, Z017DC1MS, Z017DD1MS, Z017EA1MS, Z017EB1MS, Z017FB1MS, Z017KF1MS, Z017KG1MS, Z017KH1MS
Distribution pattern: 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
Derived failure modes
-
Unknown
Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform.