Laboratory Management Software May Display Incorrect Slide Labels
TDHisto/Cyto laboratory management software may display incorrect information on slide labels in specific use cases. The FDA has issued a Class II recall affecting laboratories nationwide in California.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving incorrect label information display in a medical laboratory setting. This is a risk-of-harm product where incorrect slide labels could potentially lead to diagnostic errors, though no injuries have been reported.
Plain-English summary
TDHisto/Cyto is a software product manufactured by Technidata S.A. for managing medical information in laboratories performing histology, nongynecological and gynecological cytology, and autopsy activities. The product is subject to recall because, in specific use cases, when printing labels for slides, some labels may display incorrect information.
The software has been distributed nationwide in the state of California. This recall affects laboratories using TDHisto/Cyto software in their operations.
Laboratories using this software should contact Technidata S.A. for additional information regarding this recall and available remediation options.
The recalled product
- 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.
- Manufacturer
- Technidata S.A.
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI : 03770027519010 All TDHisto/Cyto software versions
Distribution
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