Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Normand Remisol Advance Data Manager is a software device that Recalled by Normand-Info S.A.S.U. Due to Instructions For Use for software versions 1.5 to...

Date: March 22, 2021
Company: Normand-Info S.A.S.U.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Normand-Info S.A.S.U. directly.

Affected Products

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

Quantity: 8,402 units with the affected software

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Normand-Info S.A.S.U.

Normand-Info S.A.S.U. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report