Medical device recalls Moderate risk

Technidata S.A. recalls TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histolo…

Recall date
March 27, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1573-2023
FDA classification
Class II
Brand / firm
Technidata S.A.
Sold / distributed
US Nationwide distribution in the state of CA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.

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