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Recall Observatory FDA recall evidence

Device 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.

Z-1573-2023

March 27, 2023

Class II

Product summary

Firm
Technidata S.A.
Event
Event 92184
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1573-2023

Official wording

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

Code information: UDI-DI : 03770027519010 All TDHisto/Cyto software versions

Distribution pattern: US Nationwide distribution in the state of CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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