Recall Z-1743-2013— Technidata S.A.
Class III · Terminated
Class III FDA medical device recall by Technidata S.A., initiated 2013-06-20, terminated 2013-07-29. FDA's recall record names no specific 510(k) clearance for this event. Product: TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S). Reason: 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.
- Recalling firm
- Technidata S.A.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-06-20
- Terminated
- 2013-07-29
- Firm location
- Montbonnot St Martin, N/A, France
Product description
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.