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U.S. Department of Health and Human Services

Class 2 Device Recall Remisol Advance

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 Class 2 Device Recall Remisol Advancesee related information
Date Initiated by FirmOctober 16, 2017
Create DateDecember 13, 2017
Recall Status1 Terminated 3 on February 13, 2024
Recall NumberZ-0235-2018
Recall Event ID 78394
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductRemisol 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.
Code Information Version 1.6-1.9
Recalling Firm/
Manufacturer		 Normand Informatique
Normand Informatique
Sci Git; 57 Grand place; Cs 10451
Arras CEDEX France
For Additional Information ContactBeckman Coulter representative
800-526-3821
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionBeckman 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 Commerce34 units
DistributionWorldwide Distribution - US Distribution and to the countries of : Australia, France, Germany, Israel and Russia
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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