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Normand-Info S.A.S.U. Recall 87750

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

Normand-Info S.A.S.U. Recall 87750 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1831-2021
Event ID87750
Event DescriptionNormand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Product TypeDevices
DistributionWorldwide 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.
Quantity8,402 units with the affected software
Recall ReasonInstructions 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.
Device Classification20210616
Device Code InfoCatalog Numbers: B08688; B22517; B35058; B74811; B92487 UDI: None Lot Numbers: All Lots
Center Classification Date20210608
Recall Initiation Date20210322
Recalling FirmNormand-Info S.A.S.U.
Initial Notification Letter
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