REMISOL AdvanceRecalls & reported problems across all models

We found 2 models of REMISOL Advance by Beckman Coulter, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

REMISOL Advance recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 29, 2026Open, Classified

   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.

   Z-2834-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Apr 8, 2025Open, Classified

   Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorrectly identify a patient as a newborn, affecting the execution of validation rules based on incorrect reference ranges. The test results are not changed by this software defect and are accurately displayed by REMISOL Advance; however, the evaluation flagging of the results may be affected. This issue may lead to wrong reference range calculations and can result in erroneous flagged results being auto validated and uploaded to LIS.

   Z-2028-2025 · Root cause: Software design · Recall details · FDA record ↗

REMISOL Advance models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• REMISOL Advance 2.3

  Calculator/Data Processing Module, For Clinical Use
  1 recall0 reports
• REMISOL Advance 2.4

  Calculator/Data Processing Module, For Clinical Use
  1 recall0 reports

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