Technidata TDHistology Software Recall for Electronic Transmission Symbol Errors
Technidata is recalling TDHistology/Cytology software because unsupported symbols in Microsoft Word reports may cause errors during electronic transmission of results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a software compatibility error regarding symbol support, not a direct physical hazard.
Plain-English summary
Technidata S.A. is recalling the TDHistology/Cytology Laboratory Information System (L.I.S) software. The recall was initiated because the use of specific symbols, such as less than or equal to, greater than or equal to, or other symbols, in Microsoft Word reports is not supported by the software's interface.
The issue arises when using electronic transmissions of results via HPRIM (including HPRIM Medecin via Kermit) or HL7. The source text states that the use of such symbols must be absolutely prohibited to prevent errors in the transmission process.
The recall affects all TDHistology/Cytology product versions. Distribution was limited to California, with one site affected. Users of this software should ensure that prohibited symbols are not used in Microsoft Word reports when transmitting results electronically.
The recalled product
- Product
- TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
- Manufacturer
- Technidata S.A.
- Category
- Medical Device — Software
- 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)
- All TDHistology/Cytology product versions.
Distribution
Distribution scope not specified by the agency.
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