PlainRecalls
FDA Devices Low Class III Terminated

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).

Reported: April 9, 2014 Initiated: February 17, 2014 #Z-1310-2014

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.

Details

Recalling Firm
Technidata S.A.
Units Affected
85 units total (1 unit in US)
Distribution
Distributed in the state of PA.
Location
Montbonnot St Martin, N/A

Frequently Asked Questions

What product was recalled?
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).. Recalled by Technidata S.A.. Units affected: 85 units total (1 unit in US).
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 9, 2014. Severity: Low. Recall number: Z-1310-2014.