FDA Device recall Z-1831-2021
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instr…
- FDA Device
- Class II
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class II recall of Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instr… by Normand Info S U, citing 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 us….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1831-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-22 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Normand Info S U |
| Distribution | US |
Product
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
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.
Identifiers
| code_info | Catalog Numbers: B08688; B22517; B35058; B74811; B92487 UDI: None Lot Numbers: All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1831-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.