BECKMAN COULTER INC REMISOL ADVANCE — Medical Device Explorer

Related Cybersecurity Alerts

Normand-Info S.A.S.U. 7 rue Frederic Degeorge Arras CEDEX France — Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Serv

HIGH · FDA · 2019-08-15

Normand-Info S.A.S.U. — Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Serv

HIGH · FDA · 2019-08-15

Recalls (2)

REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412; C69413; C73942; C73941; C88470; C88471 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter

2025-04-08

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 …

Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

2021-07-15

There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.

UDI Registrations (3)

REMISOL Advance

REMISOL Advance, version 2.3

REMISOL Advance

REMISOL Advance, version 2.2

REMISOL Advance

MAUDE Adverse Events (1)

Malfunction

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