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).
This recall has been terminated (originally issued March 31, 2014).
- Recall Initiated
- February 17, 2014
- Posted
- March 31, 2014
- Terminated
- March 31, 2014
- Recall Number
- Z-1310-2014
- Quantity
- 85 units total (1 unit in US)
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed in the state of PA.
Lot / Code Info
version 11.01.A or higher
Root Cause
Software design
Action Taken
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.