Reported Jul 2, 2025 · Ongoing
REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164;…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
14 of 14 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | 13700962601874 | REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487 |
| 2 | B92488 | |
| 3 | C24317 | |
| 4 | C28652 | |
| 5 | C37500 | |
| 6 | D04164 | |
| 7 | C44703 | |
| 8 | C57017 | |
| 9 | C69412 | |
| 10 | C69413 | |
| 11 | C73942 | |
| 12 | C73941 | |
| 13 | C88470 | |
| 14 | C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS&). It can also be connected to a host system. It provides data management capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing, archiving and restoration of patient results. |
- Amount recalled
- 1,805 systems
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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