Recall Z-0235-2018 ยท JQP Calculator/Data Processing Module, For Clinical Use
Normand Informatique
Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results e
| Date | Oct 16, 2017 |
| Status | Terminated |
| Reason | Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results. |
| Root cause | Software design |
| Action | Beckman Coulter sent an Urgent Medical Device Recall letter dated October 16, 2017, to all affected customers. Beckman Coulter has identified a potential issue due to a software nonconformity which could occur after a default service setting (NoCondition) is manually changed from off to on, potentially causing results outside of analytical range to be erroneously displayed. For further questions, please call (800) 526-3821. |
| Quantity | 34 units |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Australia, France, Germany, Israel and Russia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.