Recall Z-1345-2013 ยท JQP Calculator/Data Processing Module, For Clinical Use
Technidata S.A.
TD-Synergy. Laboratory Information System.
| Date | May 21, 2013 (initiated Jul 29, 2010) |
| Status | Terminated |
| Reason | Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request. |
| Root cause | Software design |
| Action | The firm, Technidata, sent an "P1 DEFECT INFORMATION" notice dated July 2, 2010 to their consignee/customers. The notice describes the product, problem and actions to be taken. The notice directs them to find the correction to the software issue on the Technidata website where they are able to install the correction kit depending on the version and operating system used. Note "You must back up the database and the installation directory before installing this correction". Should you need any further information, do not hesitate to contact the Support team at +33 (0) 4 76 04 13 00. |
| Quantity | 10 |
| Distribution | Worldwide Distribution-USA (nationwide) including Washington DC and the states of California, Nevada, Kentucky, Alabama, Rhode Island, Pennsylvania, and Louisiana and the country of Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.