Z-2743-2020Class II

Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and...

Name: Z-2743-2020 Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and...
Creator: Normand-Info S.A.S.U.
Published: 2020-04-30
License: https://open.fda.gov/license/

Normand-Info S.A.S.U. / initiated 2020-04-30 / Terminated / root cause: software

FDA source

Normand-Info S.A.S.U. began a recall of Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman... on 2020-04-30. FDA classified it as Class II and gives the reason as "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". 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-2743-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-30
Posted: 2020-07-31
Terminated: 2022-02-10
Recalling firm: Normand-Info S.A.S.U.
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2743-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2743-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-12	2020-07-31

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)