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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

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

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 Letter
Distribution Pattern US Distribution CA only.