Z-1310-2014 Class III Terminated
FDA device recall Z-1310-2014 was initiated by Technidata S.A. on February 17, 2014 and is designated Class III. 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. The recall status is terminated (terminated March 31, 2014). Affected quantity: 85 units total (1 unit in US).
Recall Details
- Product Type
- Devices
- Report Date
- April 9, 2014
- Initiation Date
- February 17, 2014
- Termination Date
- March 31, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 units total (1 unit in US)
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.
Distribution Pattern
Distributed in the state of PA.
Code Information
version 11.01.A or higher