Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 26, 2018
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
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 I…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Tecan US, Inc. recalled Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or high… - a moderate-severity action.
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or high… was recalled by Tecan US, Inc. in September 26, 2018. Reason: There is a software issue that can potentially impact sample identification and traceability under specific c…. Check the official notice for the remedy. Verify recall #Z-3187-2018 with the FDA Devices before acting.
The recall
Tecan US, Inc. issued this moderate-severity FDA Devices recall-There is a software issue that can potentially impact sample identification and traceability under specific c….
- Moderate
- severity level
- Class II
- classification
- September 26, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-3187-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-3187-2018) was formally reported on September 26, 2018, with the manufacturer initiating the action on July 23, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Tecan US, Inc. is listed as the recalling firm, operating out of Morrisville, NC. Federal records list the affected scope as 19 EVOware Sample Tracking Software Add-on.
The documented reason for this recall is: 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 30… Distribution data in the federal record shows the product reached: Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
19 EVOware Sample Tracking Software Add-on
Related Recalls
6
0 from same agency
Product description
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3187-2018 |
| Date reported | September 26, 2018 |
| Date initiated | July 23, 2018 |
| Recalling firm | Tecan US, Inc. |
| Firm location | Morrisville, NC |
| Affected scope | 19 EVOware Sample Tracking Software Add-on |
| Distribution | Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-3187-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher. Recalled by Tecan US, Inc.. Units affected: 19 EVOware Sample Tracking Software Add-on.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2018. Severity: Moderate. Recall number: Z-3187-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution to CA, MA, NC, OH, TX, and VA. Worldwide distribution to Australia, Canada, China, EU, and Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-3187-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 26, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.