DeviceSignal · Recall classified
Beckman Coulter Biomedical GmbH
FDA classified a device recall on 2026-07-31 · Class II · Z-2834-2026
EventRecall classified
Effective2026-07-31
ClassificationClass II
On 2026-07-31 the FDA classified a device recall from Beckman Coulter Biomedical GmbH as Class II. Product: REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand…. Recall Z-2834-2026. The firm initiated it on 2026-04-29. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2834-2026
- Classification
- Class II
- Classified on
- 2026-07-31
- Initiated on
- 2026-04-29
- Firm
- 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 resulting in incorrect reporting of test outcomes.
- Product
- 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
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2834-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
f12d0e1f6427ffa3fba2a65cb61b06173fca04011838b6a112b01ea2e620c610- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)