Normand-Info S.A.S.U.: Medical Device Recall in 2020 - (Recall #: Z-2743-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 30, 2020

Date Posted: August 12, 2020

Recall Number: Z-2743-2020

Event ID: 85693

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.

Status: Terminated

Product Quantity: 663

Code Information:

All serial numbers

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.

Voluntary or Mandated:

Voluntary: Firm initiated