DeviceSignal · Recall classified
Beckman Coulter Inc.
FDA classified a device recall on 2026-08-17 · Class II · Z-2973-2026
EventRecall classified
Effective2026-08-17
ClassificationClass II
On 2026-08-17 the FDA classified a device recall from Beckman Coulter Inc. as Class II. Product: Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower…. Recall Z-2973-2026. The firm initiated it on 2026-07-15. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2973-2026
- Classification
- Class II
- Classified on
- 2026-08-17
- Initiated on
- 2026-07-15
- Firm
- Beckman Coulter Inc.
- Reason
- a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.
- Product
- Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers
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-2973-2026- 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
d305abbb8ed3dec0a914915a25494e81f224f4ad68e141510a02aa2f990d0504- 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)