FDAFDA · Food and drugs·Recall number Z-2743-2020
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.
Published August 12, 2020 · Recall initiated: April 30, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Normand-Info S.A.S.U.
- Distributor
- 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.
- Lot
- All serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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