Tecan Freedom EV0-2 Software Recall for Sample Tracking Issues
Tecan US, Inc. is recalling Freedom EV0-2 devices with EVOware Sample Tracking Add-On V1.0 or higher due to a software issue that can impact sample identification and traceability.
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, and the source text explicitly states that the issue is a potential software defect with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Tecan US, Inc. is recalling Freedom EV0-2 devices equipped with any version of EVOware and the EVOware Sample Tracking Add-On V1.0 or higher. The recall involves 19 units of the EVOware Sample Tracking Software Add-on. The affected devices are distributed nationwide to California, Massachusetts, North Carolina, Ohio, Texas, and Virginia, as well as worldwide to Australia, Canada, China, the EU, and Japan.
The recall is due to a software issue that can potentially impact sample identification and traceability under specific conditions when using the EVOware Add On Software: Sample Tracking -Multi Instrument V1.0 or higher. The source text does not report any illnesses, injuries, or deaths associated with this software defect.
Users of the affected software should contact Tecan US, Inc. for further instructions on how to resolve the issue. The recall number is Z-3187-2018.
The recalled product
- Product
- Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
- Manufacturer
- Tecan US, Inc.
- Affected units
- 19
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 (20)
- 30020010
- 30032010
- b. Freedom EVO 150: 10641150
- 10641152
- 30020015
- 30032015
- c. Freedom EVO 200 Base Unit: 10641200
- 10641202
- 30020020
- 30032020
- Serial Numbers for device: 1302001540
- 1708006808
- 1208007284
- 1503007126
- 1503007304
- 905000588
- 1205002755
- 1205002802
- 1305007607
- 1308005431
Distribution
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