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Terminated

TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)

FDA Recall Z-1743-2013 · Posted 2013-07-17

Recalling FirmTechnidata S.A.
Recall StatusTerminated
Product CodeJQP
Date Initiated2013-06-20
Date Terminated2013-07-29
Product Quantity1 site

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

Firm Action

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 [email protected].

Root Cause

Software design

Distribution Pattern

US Distribution CA only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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