TD-Synergy. Laboratory Information System.
This recall has been terminated (originally issued May 21, 2013).
- Recall Initiated
- July 29, 2010
- Posted
- May 21, 2013
- Terminated
- December 5, 2013
- Recall Number
- Z-1345-2013
- Quantity
- 10
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
TD Lims product versions: LIS (ALLX)-21.041-_ML-5370, LIS (ALLX)-22.021-_ML-5374, TD-Synergy product versions: SYN (ALLX)- 03.13B-_ML-5368, SYN (ALLX)- 03.141-_ML-5369, SYN(LINUX)-06.011-_ML-5381, SYN (ALLX)-11.11B-_ML-5345, SYN (ALLX)-11.21B-_ML-5346 SYN (ALL)- 11.31C-_ML-5372, SYN (LINUX)-11.321-_FR-5382, SYN (ALL)-11.321-_ML-5373
Root Cause
Software design
Action Taken
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.