FDA Recall Open, Classified

TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.

Recall: Z-1573-2023 · Initiated March 27, 2023

Recall

Recall Number
Z-1573-2023
Event Number
92184
Firm
Technidata S.A. 387 Avenue Jean Kuntzmann Montbonnot St Martin France
FEI Number
3003995437
Product Code
JQP
Status
Open, Classified
Root Cause
Software design
Initiated
March 27, 2023
Posted
May 10, 2023

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.

Reason

In a specific use case, when printing labels for slides, some labels may display wrong information

Action

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.

Distribution

US Nationwide distribution in the state of CA.

Quantity

1 unit