Recall Z-2401-2011 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Cepheid
Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48
| Date | May 31, 2011 (initiated Apr 1, 2011) |
| Status | Terminated |
| Reason | A mismatch of Patient ID or Sample ID and the Host Order from the hosted LIS and its requested test results could occur when running in batch mode and cartridges are introduced in rapid succession. |
| Root cause | Software design |
| Action | Cepheid sent an Corrective Action Notification letter dated April 13, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cepheid recommended customers using 4.1a software on the INFINITY 48 System that is interfaced to a LIS with Host Ordering to make these alterations in operationof the system. After scanning the Patient ID (optional). Sample ID and Cartridge barcode, the host test order information should apear highlighted in the Order Test workspace. Once the highlighted host order information appears select SUBM |
| Quantity | 16 US, 3 ROW |
| Distribution | Worldwide Distribution - USA including CA, UT, TX, NJ, FL, NC, CO, IN, VT, MN and the countries of the UK, Denmark and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103766 | XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 Cepheid, Apr 21, 2011 |