Z-1743-2013 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2013
- Initiation Date
- June 20, 2013
- Termination Date
- July 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 site
Product Description
TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
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
Distribution Pattern
US Distribution CA only.
Code Information
All TDHistology/Cytology product versions.