Recall Z-1573-2023 ยท JQP Calculator/Data Processing Module, For Clinical Use
Technidata S.A.
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
| Date | May 10, 2023 (initiated Mar 27, 2023) |
| Status | Open, Classified |
| Reason | In a specific use case, when printing labels for slides, some labels may display wrong information |
| Root cause | 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 | 1 unit |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.