Technidata
MONTBONNOT ST. MARTIN Isere, FR
TECHNIDATA appears in FDA device records in MONTBONNOT ST. MARTIN Isere, FR. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003995437 | 3003995437 | TECHNIDATA | 387, AVENUE JEAN KUNTZMANN, MONTBONNOT ST. MARTIN Isere 38330 FR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1573-2023 | TDHisto/Cyto - A software product used for managing medical information in the field of laboratories performing histology, nongynecological and gynecological cytology and autopsy activities. | In a specific use case, when printing labels for slides, some labels may display wrong information | Class II | Open, Classified | |
| Z-1310-2014 | TDWorkstation version 11.01.A or higher. TDWorkstation Evolution. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS). | If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send an incorrect patient demography to an instrument. | Class III | Terminated | |
| Z-1743-2013 | TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S) | A recall was initiated by Technidata because use of symbols (less than or equal to or greater than or equal to or any other symbol) in Microsoft Word reports when using electronic transmissions of results by of HPRIM (including HPRIM Medecin via Kermit) or HL7 must be absolutely prohibited. Such symbols are not supported by the Microsoft Word interface used by the Histology/Cytology software and | Class III | Terminated | |
| Z-1345-2013 | TD-Synergy. Laboratory Information System. | Technidata has discovered that using the F8 key in the ERM session to add a combined test can result in the modification of the value of a result that has already been entered for a test of the request. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain