Atlas FDA

TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histolog

FDA device recall Z-1573-2023 · posted 2023-05-10 · Open, Classified

Recall details

Recalling firm
Technidata S.A.
Reason for recall
In a specific use case, when printing labels for slides, some labels may display wrong information
Action taken
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.
Root cause
Software design
Status
Open, Classified
Product code
JQP
Quantity affected
1 unit
Distribution
US Nationwide distribution in the state of CA.
Date initiated
2023-03-27
Date posted
2023-05-10
Location
Montbonnot St Martin, France

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