Z-1573-2023Class II

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

Name: Z-1573-2023 TDHisto/Cyto - A software product used for managing medical information in the field of laboratories...
Creator: Technidata S.A.
Published: 2023-03-27
License: https://open.fda.gov/license/

Technidata / initiated 2023-03-27 / Open, Classified / root cause: software

FDA source

Technidata S.A. began a recall of TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological... on 2023-03-27. FDA classified it as Class II and gives the reason as "In a specific use case, when printing labels for slides, some labels may display wrong information". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1573-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-27
Posted: 2023-05-10
Recalling firm: Technidata
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: In a specific use case, when printing labels for slides, some labels may display wrong information
Root cause tag: software
FDA 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 in commerce: 1 unit
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: UDI-DI : 03770027519010 All TDHisto/Cyto software versions

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1573-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1573-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-17	2023-05-10

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)