FDA recall Z-2743-2020

Normand-Info S.A.S.U. · Class II · device

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.

Reason for recall

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.

Distribution

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.

Key facts

Status: Terminated
Initiation date: 2020-04-30
Report date: 2020-08-12
Termination date: 2022-02-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Arras CEDEX, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2743-2020