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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Event Detail

Event ID 65652
Product Type Devices
Status Ongoing
Recalling Firm Technidata S.A.
City Montbonnot St Martin
Country FR
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-20
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Distribution CA only.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S) All TDHistology/Cytology product versions. Class III 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 this could potentially lead to the wrong conversion of symbols less than or equal to or greater than or equal to into "=". 1 site Z-1743-2013