Reported Jul 24, 2013 · Terminated

TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use:…

Technidata S.A.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Technidata S.A. · 387, Avenue Jean Kuntzmannn · Montbonnot St Martin, N/A · N/A

Is this the product you have?

  • TDHistology/Cytology
  • Classification nameCalculator/data processing module for clinical use (862.2100)
  • Intended useLaboratory Information System (L.I.S)
Lot codes and dates
  • All TDHistology/Cytology product versions.
Amount recalled
1 site

Where it was sold

Why it was recalled

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 product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 29, 2013 · Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.