FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2332-2021
- Recalling firm
- Beckman Coulter Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2021-07-15
- Posted
- not on file
- Terminated
- 2024-06-04
- 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 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.
- 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, Zimbabwe.
- Lot, serial or model codes
- Software Version 2.0 and 2.1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28