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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.

FDA Recall Z-1573-2023 · Posted 2023-05-10

Recalling FirmTechnidata S.A.
Recall StatusOpen, Classified
Product CodeJQP
Date Initiated2023-03-27
Product Quantity1 unit

Reason for Recall

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

Firm 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.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution in the state of CA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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