FDAFDA · Food and drugs·Recall number Z-1743-2013
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
Published July 24, 2013 · Recall initiated: June 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Technidata S.A.
- Distributor
- US Distribution CA only.
- Lot
- All TDHistology/Cytology product versions.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- France
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