Normand-Info S.A.S.U. recalls Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data a…

Recall date

April 30, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2743-2020

FDA classification

Class II

Brand / firm

Normand-Info S.A.S.U.

Sold / distributed

Worldwide distribution: US (nationwide) including states of: CA, GA, IL, IN, KS, MI, MO, NY, NC, OH, PA, SD, TN, VA, and WV; and countries of: Bahrain, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Israel, Malaysia, Netherlands, Switzerland, Taiwan,Turkey, and United Kingdom.

Why it was recalled

Results from repeated run for WBC (White Bloodcell Count), UWBC (Urine Whit Bloodcell Count) and PLT (Platelets) are deleted in RADV. Use may lead to erroneous results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system.