The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1560-2013·Announced 2013-06-26

Tecan Freedom EVO Software Recall for Door Lock Safety Defect

Tecan US, Inc. is recalling 12 Freedom EVO instruments with Touch Tools Suite 3.0 because door lock errors are ignored, potentially causing unexpected movement and operator injury.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential operator injury from unexpected movement) where no specific injuries have been reported yet, fitting the criteria for a High severity score.

Plain-English summary

Tecan US, Inc. is recalling 12 units of the Tecan Freedom EVO instrument equipped with Touch Tools Suite Version 3.0. The recall is due to a software defect where door lock errors are ignored after the execution of a Rich User Prompt in Display and Wait mode. If an operator presses "Continue" while the door is left open, the script progresses without warning, which could lead to the instrument moving unexpectedly and potentially causing injury to an operator physically inside the instrument.

The affected products are distributed worldwide, including in the United States (specifically California, Kentucky, North Carolina, Ohio, Texas, and Wisconsin) and in France, Germany, and Italy. The recall covers specific Freedom EVO 100, 150, and 200 Base Units and MCA models with specific material and serial numbers listed in the agency documentation.

Users should stop using the affected software and contact Tecan US, Inc. for further instructions on remediation or replacement.

The recalled product

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…
Manufacturer
Tecan US, Inc.
Category
Medical Device — Laboratory Automation
Hazard
Affected units
12

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • Instrument Freedom EVO 100 Base Unit: Material number: 10641100
  • Serial numbers: 1211001569
  • 1212000203 and 1212000205
  • Instrument Freedom EVO 100 MCA: Material number: 30020010
  • Serial number: 1301007643
  • Instrument Freedom EVO 150 Base Unit: Material number10641150
  • Serial number: 1301006708
  • Instrument Freedom EVO 150 MCA: Material number: 30020015
  • Serial number: 1211007442
  • Instrument Freedom EVO 150 MCA384: Material number: 30032015
  • Serial number: 1211011594 and 1109003270
  • Instrument Freedom EVO 200 Base Unit: Material number: 1641200
  • Serial number: 1208007288 and 1208007284.

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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