Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1831-2021 — Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

U.S. FDA — Device Enforcement · France · 2021-03-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1831-2021
Date of alert: 2021-03-22
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: Normand-Info S.A.S.U.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1831-2021 — Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

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