Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher

Class I - Dangerous

🏥 Medical Devices Recalled: July 23, 2018 Tecan US Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
Part Numbers for Models of Freedom EVO with any version of EVOware: a. Freedom EVO 100: 10641100, 30020010, 30032010; b. Freedom EVO 150: 10641150, 10641152, 30020015, 30032015; c. Freedom EVO 200 Base Unit: 10641200, 10641202, 30020020, 30032020; Part Numbers for Software: EVOware Sample Tracking Add-On for Multi¿ Instrument Configurations: 30019971; Serial Numbers for device: 1302001540, 1708006808, 1208007284, 1503007126, 1503007304, 905000588, 1205002755, 1205002802, 1305007607, 1308005431, 1310005144, 1310005145, 905000587, 1705007973, 904000335, 1510009082, 1109004352, 1704005194, 1007000504, 1305002594, 1307006551 and 1105004439.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Tecan US, Inc.
Reason for Recall:: There is a software issue that can potentially impact sample identification and traceability under specific conditions when using EVOware Add On Software: Sample Tracking -Multi Instrument V1.0 or higher, Part Number 30019971.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher

Product Codes/Lot Numbers:

Part Numbers for Models of Freedom EVO with any version of EVOware: a. Freedom EVO 100: 10641100, 30020010, 30032010; b. Freedom EVO 150: 10641150, 10641152, 30020015, 30032015; c. Freedom EVO 200 Base Unit: 10641200, 10641202, 30020020, 30032020; Part Numbers for Software: EVOware Sample Tracking Add-On for Multi¿ Instrument Configurations: 30019971; Serial Numbers for device: 1302001540, 1708006808, 1208007284, 1503007126, 1503007304, 905000588, 1205002755, 1205002802, 1305007607, 1308005431, 1310005144, 1310005145, 905000587, 1705007973, 904000335, 1510009082, 1109004352, 1704005194, 1007000504, 1305002594, 1307006551 and 1105004439.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3187-2018

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