FDA DeviceClass IINotable

FDA Recall: REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL A

Date: 2026-08-12
Brand: Beckman Coulter Biomedical GmbH
Category: Medical Device
FDA Class: Class II

Description

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.

Hazard

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.

Remedy

20 systems

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