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U.S. Department of Health and Human Services

Class 2 Device Recall Normand Remisol Advance Data Manager

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  Class 2 Device Recall Normand Remisol Advance Data Manager see related information
Date Initiated by Firm March 22, 2021
Create Date June 08, 2021
Recall Status1 Terminated 3 on December 30, 2022
Recall Number Z-1831-2021
Recall Event ID 87750
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Code Information Catalog Numbers: B08688; B22517; B35058; B74811; B92487  UDI: None  Lot Numbers: All Lots
Recalling Firm/
Manufacturer		 Normand-Info S.A.S.U.
7 rue Frederic Degeorge
Arras CEDEX France
Manufacturer Reason
for Recall		 Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results.
FDA Determined
Cause 2		 Labeling design
Action On 03/25/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification letter via postal mail or email to customers informing them that Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results. In a worst-case scenario, unvalidated or incorrectly validated rules may lead to the generation of erroneous test results that may be reported out of the laboratory. For customers using versions 1.5, 1.6, 1.7, 1.8 or 1.9 are instructed: 1. Validate the rules that were unvalidated or incorrectly validated, according to laboratory procedures 2. All rules set up in the future must be validated, according to laboratory procedures The Recalling Firm strongly encourages the use of the testing instructions provided with this notification, "REMISOL Avanced v1.5 through v1.9 Rule Validation Procedure". The Recalling Firm is currently updating the Instructions For Use for the affected versions and is targeting May 2021 for availability. Customer are also instructed to: -Share this information with their laboratory staff and to retain this information as part of their laboratory Quality System documentation. -If customers are a centralized license holder, they are asked to provide the other affected laboratories of their organization or association with a copy of the notification letter. -Within 10 days of receiving this customer notification, customers are asked to communicate with the Recalling Firm either: 1) Electronically, if they received this communication via email, or 2) Manually, complete and return the enclosed Response Form. For further questions, contact the Recalling Firm via -Website http://www.beckmancoulter.com or -By phone - contact their local Beckman Coulter representative.
Quantity in Commerce 8,402 units with the affected software
Distribution Worldwide distribution - US Nationwide distribution in the states of Alabama, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Texas, West Virginia and Wyoming. The countries of Australia, Austria, Belgium, Brunei, Canada, China, Colombia, Congo, Czech Republic, Denmark, Ethiopia, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Lithuania, Malaysia, Mayotte, Morocco, Netherlands, Netherlands Antillean, New Zealand, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, UAE, UK, and Zimbabwe.
Total Product Life Cycle TPLC 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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