Recall Z-2342-2016 ยท LDT
BioMerieux SA
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
| Date | Aug 9, 2016 (initiated Jul 8, 2016) |
| Status | Terminated |
| Reason | Several customer complaints about amplification performance issues when using different batches of MagSil with the NucliSENS easyMAG extraction platform. |
| Root cause | Under Investigation by firm |
| Action | Consignees were notified of the recall by letter on July 18, 2016. The letter informed them of what actions need to be taken if they experience problems. The letter included a reply form to be returned. Subsidiaries and distributors were notified electronically on 7/8/2016. |
| Quantity | 7,845 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.