Z-1345-2013Class II

TD-Synergy. Laboratory Information System

Name: Z-1345-2013 TD-Synergy. Laboratory Information System
Creator: Technidata S.A.
Published: 2010-07-29
License: https://open.fda.gov/license/

Technidata / initiated 2010-07-29 / Terminated / root cause: software

FDA source

Technidata S.A. began a recall of TD-Synergy. Laboratory Information System on 2010-07-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1345-2013
Classification: Class II
Status: Terminated
Initiated: 2010-07-29
Posted: 2013-05-21
Terminated: 2013-12-05
Recalling firm: Technidata
Product: TD-Synergy. Laboratory Information System.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1345-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1345-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-21

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)