TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histolog
Summary
The FDA issued a Class II for TDHisto/Cyto - A software product used for managing medical information in the f by Technidata S.A.. Reason: In a specific use case, when printing labels for slides, some labels may display wrong information.
Details
Source
Device Recall
External ID
Z-1573-2023
Action Date
2023-05-17
Status
Ongoing
Category
device
Product Description
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
Lot/Code Info: UDI-DI : 03770027519010 All TDHisto/Cyto software versions
Quantity Affected: 1 unit
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-27
Company
Montbonnot St Martin, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Technidata S.A.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Technidata S.A. have FDA actions?
This is the only FDA action we have on record for Technidata S.A. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1573-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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