Recall Z-1310-2014 ยท JQP Calculator/Data Processing Module, For Clinical Use
Technidata S.A.
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).
| Date | Mar 31, 2014 (initiated Feb 17, 2014) |
| Status | Terminated |
| 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. |
| 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 insta |
| Quantity | 85 units total (1 unit in US) |
| Distribution | Distributed in the state of PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.