Z-2332-2021Class II

Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that...

Name: Z-2332-2021 Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that...
Creator: Beckman Coulter Inc.
Published: 2021-07-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-07-15 / Terminated / root cause: software

FDA source

Beckman Coulter Inc. began a recall of Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS)... on 2021-07-15. FDA classified it as Class II and gives the reason as "There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2332-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-15
Posted: 2021-08-23
Terminated: 2024-06-04
Recalling firm: Siemens Healthcare Diagnostics 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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: Software Version 2.0 and 2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2332-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2332-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-01	2021-08-23

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)