REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager
Summary
The FDA issued a Class II for REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The No by Beckman Coulter Biomedical GmbH. Reason: Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results re.
Details
Source
Device Recall
External ID
Z-2834-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager collects and manages data and workflow for 128 connections
Lot/Code Info: Software Version 2.5 UDI-DI code: 15099590802073
Quantity Affected: 20 systems
Reason for Recall
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
Distribution
U.S.: FL, GA, IL, MI, and PA O.U.S.: Belgium, France, Hungary, Poland, Taiwan (Province of China), Tunisia, United Arab Emirates, and United Kingdom of Great Britain and Northern Ireland.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-29
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Beckman Coulter Biomedical GmbH has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Biomedical GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Biomedical GmbH have FDA actions?
Beckman Coulter Biomedical GmbH has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2834-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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