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U.S. Department of Health and Human Services

Class 2 Device Recall TDHisto/Cyto

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  Class 2 Device Recall TDHisto/Cyto see related information
Date Initiated by Firm March 27, 2023
Date Posted May 10, 2023
Recall Status1 Open3, Classified
Recall Number Z-1573-2023
Recall Event ID 92184
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product 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 UDI-DI : 03770027519010 All TDHisto/Cyto software versions
Recalling Firm/
Manufacturer		 Technidata S.A.
387 Avenue Jean Kuntzmann
Montbonnot St Martin France
For Additional Information Contact SAME
334 760 41300
Manufacturer Reason
for Recall		 In a specific use case, when printing labels for slides, some labels may display wrong information
FDA Determined
Cause 2		 Software design
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.
Quantity in Commerce 1 unit
Distribution US Nationwide distribution in the state of CA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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