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[Recalled] Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected

recall fda device france

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductRemisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system.
Brand / manufacturerNormand-Info S.A.S.U.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2743-2020
Country of noticeFrance
Risk levelClass II
Hazard typerecall
Notice date30 April 2020

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Results from repeated run for WBC (White Bloodcell Count), UWBC (Urine Whit Bloodcell Count) and PLT (Platelets) are deleted in RADV. Use may lead to erroneous results.

This Class II recall concerns device products distributed in France and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Normand-Info S.A.S.U.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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