Recall Z-2743-2020 ยท JQP Calculator/Data Processing Module, For Clinical Use
Normand-Info S.A.S.U.
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.
| Date | Apr 30, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | During the week of 04/27/2020, the Beckman Coulter notified affected customers via mail or email of " URGENT MEDICAL DEVICE RECALL". The letter indicated, if you are affected because your system includes one or more affected analyzers please ensure to order reruns through REMISOL and not through the analyzer until you receive the update. The resolution will be addressed by updating to the next version, version 1.12. You will be contacted by the company 's Field Associate to arrange a date and time for the upgrade to the new version. Please share this information with your laboratory staff an |
| Quantity | 663 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.