TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
This recall has been terminated (originally issued July 17, 2013).
- Recall Initiated
- June 20, 2013
- Posted
- July 17, 2013
- Terminated
- July 29, 2013
- Recall Number
- Z-1743-2013
- Quantity
- 1 site
- Official Source
- View on FDA website ↗
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
Distribution
US Distribution CA only.
Lot / Code Info
All TDHistology/Cytology product versions.
Root Cause
Software design
Action Taken
TD Technidata Medical Software sent a Medical Device Recall letter dated June 20, 2013, to one affected customer who received the TD-Synergy Histology/Cytology module. The customer was informed of the problems identified and the actions to be taken. Customers were instructed to complete the attached Reply Form and return it to the firm by fax to 514-270.2770. The customer were also instructed to contact Technidata Canada at (514) 270-7777 or at support-canada@technidata-web.com.