Home / Recalls / Normand-Info S.A.S.U. / Z-1831-2021

Z-1831-2021 Class II Terminated

Recalled by Normand-Info S.A.S.U. — Arras CEDEX, N/A

Recall Details

Product Type: Devices
Report Date: June 16, 2021
Initiation Date: March 22, 2021
Termination Date: December 30, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,402 units with the affected software

Product Description

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

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.

Distribution Pattern

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.

Code Information

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