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 Insight

This FDA Devices action (record #Z-1310-2014) was formally reported on April 9, 2014, with the manufacturer initiating the action on February 17, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Technidata S.A. is listed as the recalling firm, operating out of Montbonnot St Martin, N/A. Federal records indicate 85 units total (1 unit in US) units are affected.

The documented reason for this recall is: 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 data in the federal record shows the product reached: Distributed in the state of PA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.