Z-1831-2021Class II

Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information...

Name: Z-1831-2021 Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information...
Creator: Normand-Info S.A.S.U.
Published: 2021-03-22
License: https://open.fda.gov/license/

Normand-Info S.A.S.U. / initiated 2021-03-22 / Terminated / root cause: labeling and UDI

FDA source

Normand-Info S.A.S.U. began a recall of Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments on 2021-03-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1831-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-22
Posted: 2021-06-08
Terminated: 2022-12-30
Recalling firm: Normand-Info S.A.S.U.
Product: Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Catalog Numbers: B08688; B22517; B35058; B74811; B92487 UDI: None Lot Numbers: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1831-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1831-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-08

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)