CLASS II ONGOING Device recall · Reported 26 Aug 2026 · FDA Enforcement Report
DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter
Beckman Coulter is recalling DxC 500 AU Clinical Analyzer Modules using, distributed nationwide in the US. The recall was initiated on 15 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2974-2026
- FDA event ID
- 99436
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 15 Jul 2026
- FDA classified
- 17 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 15 Jul 2026 | Recall initiated by company | |
| 17 Aug 2026 | Classified by FDA | +33 days |
| 26 Aug 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers
Where it was distributed
Worldwide distribution - US Nationwide.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065
Where was it sold?
Worldwide distribution - US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99436| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
More recalls from Beckman Coulter
All 334| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US) recalled | Beckman Coulter | Other | Nationwide |
| Device | CLASS II | REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) recalled | Beckman Coulter | Other | Nationwide |
| Device | CLASS II | Access Total T4 Calibrator recalled by Beckman Coulter | Beckman Coulter | Other | Nationwide |
| Device | CLASS II | MicroScan Neg Multidrug Resistant MIC recalled by Beckman Coulter | Beckman Coulter | Device Malfunction | CA |
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