TDHisto/Cyto - A software product used for managing medical… recallZ-1573-2023 · Technidata S.A. · initiated Mar 27, 2023
Class II Open, Classified All recalls posted in May 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Technidata S.A. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
In a specific use case, when printing labels for slides, some labels may display wrong information
FDA root cause category: Software design
What the company is doing
Techidata issued Medical Device Recall Urgent letter via email on 3/27/23. Letter states reason for recall, health risk and action to take: To prevent any occurrence of the issue, you must not close the current session, or open another one, or perform the printing of another label batch, until the label printing is finished. Note: printing is finished when the Printing dialog box closes. software modification was performed to prevent the risks mentioned above. We kindly ask you to fill the reply form below and return it to us at your earliest convenience.
Recall details
- Recall number
- Z-1573-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 27, 2023
- Posted by the FDA
- May 10, 2023
- Recalling firm
- Technidata S.A.
- Quantity
- 1 unit
- Product code
- JQP
- Distribution
- US Nationwide distribution in the state of CA.
Product description
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
Code information (models, lots, serial numbers)
UDI-DI : 03770027519010 All TDHisto/Cyto software versions
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TDHisto/CytoTechnidata · Calculator/Data Processing Module, For Clinical Use1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page