Beckman Coulter Remisol Advance Software Recalled for Potential Wrong Results
Beckman Coulter is recalling Remisol Advance Software versions 1.6-1.9 because a software nonconformity may cause the system to display incorrect results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 defect that could lead to incorrect patient results, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Beckman Coulter has identified a software nonconformity in the Remisol Advance Software (Driver Architect), Catalog Number B32129. This issue is connected to a changed service setting and may cause the Remisol system to display wrong results. The Remisol Advance Data Manager is a stand-alone system used to collect and manage data and workflows for connected systems, including Beckman Coulter instruments, automations, and Laboratory Information Systems (LIS).
The recall affects 34 units of Remisol Advance Software, specifically versions 1.6 through 1.9. The product was distributed worldwide, including in the United States, Australia, France, Germany, Israel, and Russia. The software provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, and results editing.
Users of the affected software should contact Beckman Coulter or Normand Informatique for further instructions on how to address the software nonconformity and ensure accurate data management.
The recalled product
- Product
- Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It…
- Manufacturer
- Normand Informatique
- Affected units
- 34
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)
- Version 1.6-1.9
Distribution
Distribution scope not specified by the agency.
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