TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: L

FDA device recall Z-1743-2013 · posted 2013-07-17 · Terminated

Recall details

Recalling firm

Technidata S.A.

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

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.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

1 site

Distribution

US Distribution CA only.

Date initiated

2013-06-20

Date posted

2013-07-17

Date terminated

2013-07-29

Location

Montbonnot St Martin, France