Home / Recalls / Normand-Info S.A.S.U. / Z-2743-2020

Z-2743-2020 Class II Terminated

Recalled by Normand-Info S.A.S.U. — Arras CEDEX

Recall Details

Product Type: Devices
Report Date: August 12, 2020
Initiation Date: April 30, 2020
Termination Date: February 10, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 663

Product Description

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 Pattern

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.

Code Information

All serial numbers