Recall Z-1831-2021— Normand-Info S.A.S.U.
Class II · Terminated
Class II FDA medical device recall by Normand-Info S.A.S.U., initiated 2021-03-22, terminated 2022-12-30. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Normand-Info S.A.S.U.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-22
- Terminated
- 2022-12-30
- Firm location
- Arras CEDEX, N/A, France
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.