Normand-Info S.A.S.U. 7 rue Frederic Degeorge Arras CEDEX France 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.