Normand-Info S.A.S.U.: Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

Recall number

Z-1831-2021

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.

Status

Terminated

Initiated

2021-03-22

Posted

not on file

Terminated

2022-12-30

Reason

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

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

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.

Lot, serial or model codes

Catalog Numbers: B08688; B22517; B35058; B74811; B92487  UDI: None  Lot Numbers: All Lots

510(k) numbers

not on file

PMA numbers

not on file

Product code

JQP

Firm FEI

3006543086

Firm city

CEDEX

Firm state

not on file

Firm country

France

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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