Reported Apr 9, 2014 · Terminated

TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a…

Technidata S.A.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Technidata S.A. · 387, Avenue Jean Kuntzmannn · Montbonnot St Martin, N/A · N/A

Is this the product you have?

  • 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).
Lot codes and dates
  • version 11.01.A or higher
Amount recalled
85 units total (1 unit in US)

Where it was sold

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 31, 2014 · Data as of Sep 19, 6:48 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.