Recall Z-2548-2016 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Cepheid
Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization
| Date | Jul 18, 2016 |
| Status | Terminated |
| Reason | Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations. |
| Root cause | Nonconforming Material/Component |
| Action | Recall letters dated July 18, 2016 were sent to affected customers on July 19, 2016 by Federal Express. Letters advised users of the affected product and asked that any remaining inventory be destroyed. |
| Quantity | 68 kit for lot 1000037539 and 127 kit s for lot 1000029307. |
| Distribution | US only: PA, DE, FL, SC, ME, CA, IL, NC, TX, WA, NY, TN, FL, OR, OK, MO, MS, GA, NM, IN, OH, MD, VA, CO, AZ, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070462 | XPERT MRSA Cepheid, Apr 17, 2007 |