Recall Z-2743-2020— Normand-Info S.A.S.U.
Class II · Terminated
Class II FDA medical device recall by Normand-Info S.A.S.U., initiated 2020-04-30, terminated 2022-02-10. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Normand-Info S.A.S.U.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-30
- Terminated
- 2022-02-10
- Firm location
- Arras CEDEX, France
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.