Beckman Coulter recalls REMISOL Advance units with specific UDI-DI codes and software versions due to a software defect that may incorrectly identify newborn patients, affecting validation rules and reference ranges.
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.
Beckman Coulter is recalling certain REMISOL Advance units with specific UDI-DI codes and software versions. The software may incorrectly process a patient's date of birth as 01/01/1900 or empty, causing the system to flag them as newborns and potentially leading to wrong reference range calculations and erroneous results being auto-validated.
The software defect causes the system to incorrectly interpret a patient's date of birth as 01/01/1900 or empty. This leads the system to treat the patient as a newborn, which can cause incorrect reference range calculations and result in erroneous flagged results being auto-validated and uploaded to the laboratory information system.
Healthcare facilities using REMISOL Advance units with the affected UDI-DI code and software versions are most at risk. Patients may be misidentified as newborns, but the test results themselves remain accurate.
Check if your REMISOL Advance unit has the UDI-DI code 13700962601874 and software versions B92487, B92488, C24317, C28652, C37500, D04164, or other listed versions. The system serial numbers are also listed in the recall notice.
Verify your REMISOL Advance software version against the list of affected versions provided in the recall notice.
Reach out to Beckman Coulter for guidance on next steps if your unit is affected.
No, the test results themselves remain accurate. The issue only affects the evaluation flags and reference range calculations.
Contact Beckman Coulter directly for specific instructions on how to address the issue.
The issue does not pose a direct safety risk to users, but it could lead to incorrect patient identification and potential errors in validation rules.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2028-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2028-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
