FDA Recall Terminated

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).

Recall: Z-1310-2014 · Initiated February 17, 2014

Recall

Recall Number
Z-1310-2014
Event Number
67628
Firm
Technidata S.A. 387, Avenue Jean Kuntzmannn Montbonnot St Martin France
FEI Number
3003995437
Product Code
JQP
Status
Terminated
Root Cause
Software design
Initiated
February 17, 2014
Posted
March 31, 2014
Terminated
March 31, 2014

Description

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).

Reason

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.

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.

Distribution

Distributed in the state of PA.

Quantity

85 units total (1 unit in US)