Recall Z-1310-2014— Technidata S.A.

Class III · Terminated

Class III FDA medical device recall by Technidata S.A., initiated 2014-02-17, terminated 2014-03-31. FDA's recall record names no specific 510(k) clearance for this event. 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).. 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..

Recalling firm
Technidata S.A.
Classification
Class III
Status
Terminated
Initiated
2014-02-17
Terminated
2014-03-31
Firm location
Montbonnot St Martin, N/A, France

Product 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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.