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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 Advance see related information
Date Initiated by Firm April 30, 2020
Create Date July 31, 2020
Recall Status1 Open3, Classified
Recall Number Z-2743-2020
Recall Event ID 85693
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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.
Code Information All serial numbers
Recalling Firm/
Manufacturer
Normand-Info S.A.S.U.
7 rue Frederic Degeorge
Arras CEDEX France
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Software design
Action During the week of 04/27/2020, the Beckman Coulter notified affected customers via mail or email of " URGENT MEDICAL DEVICE RECALL". The letter indicated, if you are affected because your system includes one or more affected analyzers please ensure to order reruns through REMISOL and not through the analyzer until you receive the update. The resolution will be addressed by updating to the next version, version 1.12. You will be contacted by the company 's Field Associate to arrange a date and time for the upgrade to the new version. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you are a centralized license holder, please provide the other affected laboratories of your organization or association with a copy of this letter. So that the firm are assured you have received this important communication, please respond within 10 days in one of the following ways: - Electronically, if you received this communication via email. - Manually, complete and return the enclosed Response Form. Return completed form via email or fax at (714) 961-4234. If you have any questions regarding this notice, please contact the company via the firm's website or by phone by contacting your local representative. Firm telephone is (800) 526-3821.
Quantity in Commerce 663
Distribution Worldwide distribution: US (nationwide) including states of: CA, GA, IL, IN, KS, MI, MO, NY, NC, OH, PA, SD, TN, VA, and WV; and countries of: Bahrain, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Israel, Malaysia, Netherlands, Switzerland, Taiwan,Turkey, and United Kingdom.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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