Z-1743-2013Class III

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

Name: Z-1743-2013 TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100)
Creator: Technidata S.A.
Published: 2013-06-20
License: https://open.fda.gov/license/

Technidata / initiated 2013-06-20 / Terminated / root cause: software

FDA source

Technidata S.A. began a recall of TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S) on 2013-06-20. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1743-2013
Classification: Class III
Status: Terminated
Initiated: 2013-06-20
Posted: 2013-07-17
Terminated: 2013-07-29
Recalling firm: Technidata
Product: TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S)
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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
Root cause tag: software
FDA root cause: Software design
Action: TD Technidata Medical Software sent a Medical Device Recall letter dated June 20, 2013, to one affected customer who received the TD-Synergy Histology/Cytology module. The customer was informed of the problems identified and the actions to be taken. Customers were instructed to complete the attached Reply Form and return it to the firm by fax to 514-270.2770. The customer were also instructed to contact Technidata Canada at (514) 270-7777 or at [email protected].
Quantity in commerce: 1 site
Distribution: US Distribution CA only.
Product codes and lots: All TDHistology/Cytology product versions.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1743-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1743-2013	Class III	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-17

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)