TD-Synergy. Laboratory Information System.

FDA device recall Z-1345-2013 · posted 2013-05-21 · Terminated

Recall details

Recalling firm

Technidata S.A.

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.

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.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

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.

Date initiated

2010-07-29

Date posted

2013-05-21

Date terminated

2013-12-05

Location

Montbonnot St Martin, France