Company: Technidata S.A.
Date of Enforcement Report: 7/24/2013
Class llI:
PRODUCT
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
REASON
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 “=”.
RECALLING FIRM/MANUFACTURER
Technidata S.A., Montbonnot St Martin, FR on 6/20/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1 site
DISTRIBUTION
US Distribution CA only
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