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U.S. Department of Health and Human Services

Class 2 Device Recall Normand Info Remisol Advance Data Manager

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  Class 2 Device Recall Normand Info Remisol Advance Data Manager see related information
Date Initiated by Firm July 15, 2021
Create Date August 23, 2021
Recall Status1 Terminated 3 on June 04, 2024
Recall Number Z-2332-2021
Recall Event ID 88339
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
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.
Code Information Software Version 2.0 and 2.1
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Johanna Hecker
714-961-5321
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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