Beckman Coulter Biomedical GmbH recalls REMISOL Advance with Software Version 2.5 UDI-DI code: 1509
See all recalls from Beckman Coulter Biomedical GmbH →Recalled Product
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
Hazard / Issue
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.
Issued by
FDA
Affected States: FL, GA, IL, MI, PA
Lot/Code Info: Software Version 2.5 UDI-DI code: 15099590802073
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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