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).
FDA Recall Z-1310-2014 · Posted 2014-03-31
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Recalling FirmTechnidata S.A.
Recall StatusTerminated
Product CodeJQP
Date Initiated2014-02-17
Date Terminated2014-03-31
Product Quantity85 units total (1 unit in US)
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Distributed in the state of PA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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