Technidata TDWorkstation Software Recalled for Potential Incorrect Patient Demography Transmission
Technidata S.A. is recalling TDWorkstation software versions 11.01.A and higher because a conflict may cause the system to send incorrect patient demography to connected instruments.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard is a data integrity issue rather than a direct physical injury risk.
Plain-English summary
Technidata S.A. is recalling TDWorkstation version 11.01.A or higher and TDWorkstation Evolution. This software is used to receive patient results from connected instruments and send them to a Laboratory Information System (LIS). The recall involves 85 units total, with 1 unit distributed in the United States, specifically in the state of Pennsylvania.
The recall is due to a potential software conflict. 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 could result in patient data being associated with the wrong individual.
The U.S. Food and Drug Administration has classified this as a Class III recall. Users of the affected software should contact Technidata S.A. for instructions on how to resolve the issue.
The recalled product
- Product
- 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).
- Manufacturer
- Technidata S.A.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- version 11.01.A or higher
Distribution
Distributed in 1 state:
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