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

Recall Insight

This FDA Devices action (record #Z-1743-2013) was formally reported on July 24, 2013, with the manufacturer initiating the action on June 20, 2013. It is classified under Low severity (Class III), with a current status of Terminated. Technidata S.A. is listed as the recalling firm, operating out of Montbonnot St Martin, N/A. Federal records indicate 1 site units are affected.

The documented reason for this recall is: 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 (i… Distribution data in the federal record shows the product reached: US Distribution CA only.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.