Tecan Freedom EVO-2 100 Base Unit Recalled for Liquid Level Interference
Tecan US, Inc. is recalling two Freedom EVO-2 100 Base Units because noise interference may cause air aspiration instead of liquid, leading to erroneous laboratory results.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to erroneous laboratory results due to dispense errors rather than direct physical injury or death, fitting the criteria for a moderate severity issue involving potential data integrity risks.
Plain-English summary
Tecan US, Inc. is recalling two units of the Freedom EVO-2 100 Base Unit, an open automation platform intended for routine laboratory tasks such as general purpose pipetting and liquid handling. The recall is due to distortion (noise interference) of the liquid level capacitance, which can result in air aspiration instead of liquid aspiration.
This defect may cause a false signal (air detection) and possible dispense errors, resulting in erroneous laboratory results. The affected units are identified by Part Number 10641100 and Serial Number 1407006311. The products were distributed in the United States to Illinois.
No specific consumer action is detailed in the source text beyond the identification of the affected units. Users of these specific laboratory automation units should verify their serial numbers against the recall information provided by the manufacturer.
The recalled product
- Product
- Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.
- Manufacturer
- Tecan US, Inc.
- Affected units
- 2
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 (2)
- Part Number: 10641100
- SN: 1407006311.
Distribution
Distributed in 1 state:
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