Recall Z-2332-2021 ยท JQP Calculator/Data Processing Module, For Clinical Use
Beckman Coulter Inc.
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
| Date | Jul 15, 2021 |
| Status | Terminated |
| Reason | There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result. |
| Root cause | Software design |
| Action | On July 15, 2021, Beckman Coulter issued an "Urgent Medical Device" Recall letter to affected consignees via postal mail and email. In addition to informing consignees about the recall, Beckman Coulter asked consignees to take the following actions: 1. Please follow the instructions attached to reset the configuration of the keyboard to non-numerical values (Annex I). 2. Please confirm your Remisol Advance Software version by opening the software. The software version can be found at the bottom left of the program window. If you are not using the impacted software version, you do not need |
| Quantity | 180 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Al, CA, FL, GA, IL, IN, MA, NC, OH, PA, TN, TX and the countries of Australia, Belgium, Canada, China, Czech Republic, France, Italy, Netherlands, New Zealand, Poland, Russia, Switzerland, Taiwan, United Kingdom, United States, Zim |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.