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Terminated

TD-Synergy. Laboratory Information System.

FDA Recall Z-1345-2013 · Posted 2013-05-21

Recalling FirmTechnidata S.A.
Recall StatusTerminated
Product CodeJQP
Date Initiated2010-07-29
Date Terminated2013-12-05
Product Quantity10

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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