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.
- Company
- Beckman Coulter Inc.
- Recall Initiated
- July 15, 2021
- Terminated
- June 4, 2024
- Recall Number
- Z-2332-2021
- Quantity
- 180 units
- Firm Location
- Brea, CA
Reason for Recall
There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.
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, Zimbabwe.
Lot / Code Info
Software Version 2.0 and 2.1
Root Cause
Software design
Action Taken
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 to take any action. 3. Resolution: Beckman Coulter is currently working on an update for the affected versions. Beckman Coulter Service personnel will contact you when the update is available. 4. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. 5. Quality System documentation. If you are a centralized license holder, please provide the other affected laboratories of your organization or association with a copy of this letter. 6. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. 7. If you have any questions regarding this notice, please contact Beckman Coulter via: " Our website: http://www.beckmancoulter.com " By phone: contact your local Beckman Coulter representative.