Reported Dec 20, 2017 · Terminated
Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data…
Normand Informatique
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Normand Informatique · Normand Informatique · Arras CEDEX, N/A · N/A
Is this the product you have?
- 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 provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console.
- Lot codes and dates
- Version 1.6-1.9
- Amount recalled
- 34 units
Why it was recalled
Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.
This product could cause temporary or reversible health problems — stop using it.
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