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U.S. Department of Health and Human Services

Class 3 Device Recall TDHisto/Cytology

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  Class 3 Device Recall TDHisto/Cytology see related information
Date Initiated by Firm June 20, 2013
Date Posted July 17, 2013
Recall Status1 Terminated 3 on July 29, 2013
Recall Number Z-1743-2013
Recall Event ID 65652
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product TDHistology/Cytology

Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
Code Information All TDHistology/Cytology product versions.
Recalling Firm/
Manufacturer		 Technidata S.A.
387, Avenue Jean Kuntzmannn
Montbonnot St Martin France
Manufacturer 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
FDA Determined
Cause 2		 Software design
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 support-canada@technidata-web.com.
Quantity in Commerce 1 site
Distribution US Distribution CA only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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