Recall Z-1378-05 ยท NSR Prosthesis, Orthodontic
Cepheid
SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
| Date | Aug 17, 2005 (initiated Jul 22, 2005) |
| Status | Terminated |
| Reason | A problem in the software has the potential to be associated with the incorrect reporting of sample results. |
| Root cause | Other |
| Action | On 7/22/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the corrective action. |
| Distribution | The product was distributed nationally to 94 consignees directly to medical facilities and internationally to 25 consignees via distributors. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033415 | IDI-MRSA Infectio Diagnostic (I.D.I.), Inc., Mar 18, 2004 |