Tecan Freedom EVO with Touch Tools Suite Version 3 — Class II medical device recall Z-1560-2013
Terminated recall by Tecan US, Inc., reported 2013-06-26, distributed nationwide. WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock errors are i
| Recall number | Z-1560-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tecan US, Inc., Morrisville, NC, United States |
| Recall initiated | 2013-02-19 |
| Classified | 2013-06-19 |
| Reported by FDA | 2013-06-26 |
| Terminated | 2013-06-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, FR, IT |
| Quantity | 12 units |
| Serial numbers | 1106003923, 1109003270, 1208007284, 1208007288, 1211001569, 1211007442, 1211011578, 1211011594, 1212000203, 1212000205, 1301006708, 1301007643 |
Product
Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software for the Freedom EVO 2 instrument.
Reason for recall
WIth TouchTools 3.0 after the execution of a Rich User Prompt in Display and Wait mode, door lock errors are ignored. If an operator presses "Continue" following a Rich User Prompt and the door has been left open, the script will progress (continue without warning). This could lead to the instrument moving unexpectedly and potentially cause an injury to the operator if they are physically inside t
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1560-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.