REMISOL Advance Software Version 2.5 Recalled for Incorrect Test Result Reporting
Beckman Coulter Biomedical GmbH is recalling REMISOL Advance Software Version 2.5 because it may incorrectly report combo assay test outcomes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software error that results in incorrect reporting of test outcomes, posing a high risk of harm due to potential diagnostic errors.
Plain-English summary
Beckman Coulter Biomedical GmbH has issued a recall for REMISOL Advance with Software Version 2.5 (UDI-DI code: 15099590802073). This software is used by the Normand Info REMISOL Advance Data Manager to collect and manage data and workflow for up to 128 connections.
The recall is due to a software issue where the system does not correctly handle combo assay results. Specifically, the software may replace a final combo test result with one of the sub-results, leading to the reporting of incorrect test outcomes.
This recall affects 20 systems distributed in the U.S. (FL, GA, IL, MI, and PA) and internationally in Belgium, France, Hungary, Poland, Taiwan, Tunisia, United Arab Emirates, and the United Kingdom.
The recalled product
- 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
- Manufacturer
- Beckman Coulter Biomedical GmbH
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software Version 2.5 UDI-DI code: 15099590802073
Distribution
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