REMISOL Advance Software Version 2.5 Recall
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Beckman Coulter Biomedical GmbH is recalling 20 REMISOL Advance systems due to software issues that may cause incorrect reporting of combo assay test results.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States (FL, GA, IL, MI, PA) and international. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Beckman Coulter Biomedical GmbH initiated a voluntary recall of REMISOL Advance with Software Version 2.5 due to software issues where the system 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.
Which Products Are Affected
The recall affects 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. A total of 20 systems are affected. Distribution includes U.S. states FL, GA, IL, MI, and PA, as well as Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland. Recall number Z-2834-2026. Code info: Software Version 2.5 UDI-DI code: 15099590802073.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the affected systems.
Why This Matters
The software defect may lead to incorrect reporting of test outcomes on the affected systems.
Source
FDA recall Z-2834-2026, https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,215 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.