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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
Recalled August 12, 2020 · FDA recall Z-2743-2020 · Normand-Info S.A.S.U
Hazard
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. · FDA Class II
Units
663
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Normand-Info S.A.S.U.
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →