Jun

2021

Recall – Insufficiently written IFU may lead to erroneous results

Company: Normand-Info S.A.S.U.
Date of Enforcement Report: 6/16/2021
Class II

PRODUCT

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

Recall Number: Z-1831-2021

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/MANUFACTURER

Normand-Info S.A.S.U. on 4/19/2021. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

8,402 units with the affected software

DISTRIBUTION

U.S. Nationwide and International

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Recall – Insufficiently written IFU may lead to erroneous results

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