Z-0235-2018Class II

Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand...

Name: Z-0235-2018 Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand...
Creator: Normand Informatique
Published: 2017-10-16
License: https://open.fda.gov/license/

Normand-Info S.A.S.U. / initiated 2017-10-16 / Terminated / root cause: software

FDA source

Normand Informatique began a recall of Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages... on 2017-10-16. FDA classified it as Class II and gives the reason as "Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0235-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-16
Posted: 2017-12-13
Terminated: 2024-02-13
Recalling firm: Normand-Info S.A.S.U.
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 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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated October 16, 2017, to all affected customers. Beckman Coulter has identified a potential issue due to a software nonconformity which could occur after a default service setting (NoCondition) is manually changed from off to on, potentially causing results outside of analytical range to be erroneously displayed. For further questions, please call (800) 526-3821.
Quantity in commerce: 34 units
Distribution: Worldwide Distribution - US Distribution and to the countries of : Australia, France, Germany, Israel and Russia
Product codes and lots: Version 1.6-1.9

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0235-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0235-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-20	2017-12-13

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)