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

Recall date

March 22, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1831-2021

FDA classification

Class II

Brand / firm

Normand-Info S.A.S.U.

Sold / distributed

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 Ham…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.