FDA recall Z-1573-2023

Technidata S.A. · Class II · 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.

Reason for recall

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

Distribution

US Nationwide distribution in the state of CA.

Key facts

Status
Ongoing
Initiation date
2023-03-27
Report date
2023-05-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Montbonnot St Martin, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1573-2023