The Recall Desk
HighFDA (Devices)·Z-2743-2020·Announced 2020-08-12

Normand-Info Remisol Advance Software Recall for Erroneous Lab Results

Normand-Info is recalling Remisol Advance software version 1.12 because it deletes specific white blood cell and platelet results, potentially leading to erroneous data.

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 is classified as FDA Class II. The hazard involves the deletion of critical laboratory data (WBC, UWBC, PLT), which may lead to erroneous results and potential patient harm, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Normand-Info S.A.S.U. is recalling Remisol Advance running Software Version 1.12. The Normand Info Remisol Advance Data Manager is a software system that collects and manages data and workflow for 128 connections, including Beckman Coulter Instruments, automations, and Laboratory Information Systems (LIS). The software can also be connected to a host system.

The recall is being issued because results from repeated runs for White Blood Cell Count (WBC), Urine White Blood Cell Count (UWBC), and Platelets (PLT) are deleted in the RADV system. The use of this software may lead to erroneous results.

A total of 663 units are affected by this recall. The products were distributed worldwide, including nationwide in the United States (specifically in CA, GA, IL, IN, KS, MI, MO, NY, NC, OH, PA, SD, TN, VA, and WV) and in countries such as Bahrain, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Israel, Malaysia, Netherlands, Switzerland, Taiwan, Turkey, and the United Kingdom. Users should contact the recalling firm for further instructions.

The recalled product

Product
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 to a host system.
Manufacturer
Normand-Info S.A.S.U.
Category
Medical Device — Laboratory Software
Hazard
Affected units
663

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)

  • All serial numbers

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

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