medical Class II Updated 2021-06-16

Normand-Info S.A.S.U. recalls Normand Remisol Advance Data Manager is a software device th

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Numbers: B08688; B22517; B35058; B74811; B92487 UDI: None Lot Numbers: All Lots
View official government recall

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