FDA Devices recall · Reported August 12, 2026
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reportin…
Beckman Coulter Biomedical GmbH recalled REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Inf… - a moderate-severity action.
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Inf… was recalled by Beckman Coulter Biomedical GmbH in August 12, 2026. Reason: Due to software issues where does not handle combo assay results. The software may replace the final combo t…. Check the official notice for the remedy. Verify recall #Z-2834-2026 with the FDA Devices before acting.
The recall
Beckman Coulter Biomedical GmbH issued this moderate-severity FDA Devices recall-Due to software issues where does not handle combo assay results. The software may replace the final combo t….
- Moderate
- severity level
- Class II
- classification
- August 12, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2834-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2834-2026) was formally reported on August 12, 2026, with the manufacturer initiating the action on April 29, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Beckman Coulter Biomedical GmbH is listed as the recalling firm, operating out of Munchen. Federal records list the affected scope as 20 systems.
The documented reason for this recall is: Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes. Distribution data in the federal record shows the product reached: U.S.: FL, GA, IL, MI, and PA O.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland.. 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, 6 from FDA Devices - 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
Reason for recall
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2834-2026 |
| Date reported | August 12, 2026 |
| Date initiated | April 29, 2026 |
| Recalling firm | Beckman Coulter Biomedical GmbH |
| Firm location | Munchen |
| Affected scope | 20 systems |
| Distribution | U.S.: FL, GA, IL, MI, and PA O.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland. |
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-2834-2026) 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.
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Similar severity · nearest report date
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Methodology · Corrections · Archive as of August 2026