CLASS II ONGOING Device recall · Reported 17 May 2023 · FDA Enforcement Report
TDHisto/Cyto recalled by Technidata
Technidata is recalling TDHisto/Cyto - A, distributed nationwide in the US. The recall was initiated on 27 Mar 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1573-2023
- FDA event ID
- 92184
- Recalling firm
- Technidata, Montbonnot St Martin, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Mar 2023
- FDA classified
- 10 May 2023
- Reported
- 17 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 27 Mar 2023 | Recall initiated by company | |
| 10 May 2023 | Classified by FDA | +44 days |
| 17 May 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In a specific use case, when printing labels for slides, some labels may display wrong information
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities.
Where it was distributed
US Nationwide distribution in the state of CA.
Questions about this recall
Is TDHisto/Cyto - A recalled?
Yes. Technidata recalled TDHisto/Cyto - A on 27 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1573-2023.
Why was it recalled?
In a specific use case, when printing labels for slides, some labels may display wrong information
Which lots are affected?
UDI-DI : 03770027519010 All TDHisto/Cyto software versions
Where was it sold?
US Nationwide distribution in the state of CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Technidata
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|---|---|---|---|---|---|
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