Beckman Coulter Biomedical GmbH: 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 conn

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.

Details from the source

Reason for recall: 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. Distribution: U.S.: FL, GA, IL, MI, and PA O.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland. Quantity: 20 systems Lot/code info: Software Version 2.5 UDI-DI code: 15099590802073

UPC codes

15099590802073

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.