Z-1310-2014Class III

TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from...

Name: Z-1310-2014 TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from...
Creator: Technidata S.A.
Published: 2014-02-17
License: https://open.fda.gov/license/

Technidata / initiated 2014-02-17 / Terminated / root cause: software

FDA source

Technidata S.A. began a recall of TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a... on 2014-02-17. FDA classified it as Class III and gives the reason as "If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument". 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-1310-2014
Classification: Class III
Status: Terminated
Initiated: 2014-02-17
Posted: 2014-03-31
Terminated: 2014-03-31
Recalling firm: Technidata
Product: TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS).
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument.
Root cause tag: software
FDA root cause: Software design
Action: An email dated 2/17/14 was sent to their customers to inform them about concerns only if their site uses TDWorkstation and TD-Workstation Evolution products that meet all the listed criterias. The criterias are listed in the customer notification letter and it informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the reply form and return it by fax (514) 270-2770 with in 15 days from receiving the customer notification form. Customers that do not respond the reply form, Technidata will consider those customers do not wish to install the correction.
Quantity in commerce: 85 units total (1 unit in US)
Distribution: Distributed in the state of PA.
Product codes and lots: version 11.01.A or higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1310-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1310-2014	Class III	Terminated	Voluntary: Firm initiated	2014-04-09	2014-03-31

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)