Recall Z-0453-2012 ยท NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Cepheid
Cepheid brand Xpert MRSA/SA-BC US-IVD, an In-vitro diagnostic test kit, Catalog Numbers: GXMRSA/SA-BC-10, Lots Affected: 2803 and 3001;
| Date | Jan 11, 2012 (initiated Nov 17, 2011) |
| Status | Terminated |
| Reason | Cepheid has received reports from some of its customers regarding higher than desired (>5%) rates of invalid results when using lot numbers 2803 and 3001 of the Xpert MRSA/SA BC (blood culture) product. |
| Root cause | Nonconforming Material/Component |
| Action | On 11/17/11, Cepheid issued letters via mail to all its direct consignees, informing them of the affected products and providing instructions on the recall. |
| Quantity | 1289 |
| Distribution | Product was released for distribution in US. |
| FDA record | Open on fda.gov |