Skip to content
Recall Observatory FDA recall evidence

Device product

TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)

Z-1743-2013

June 20, 2013

Class III

Product summary

Firm
Technidata S.A.
Event
Event 65652
Status
Terminated
Classification
Class III
Quantity
1 site
Official record key
device-enforcement:Z-1743-2013

Official wording

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

Code information: All TDHistology/Cytology product versions.

Distribution pattern: US Distribution CA only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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