CLASS II ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report
DxI 600 Access Immunoassay Analyzer W/Dual Gantry recalled
Beckman Coulter is recalling DxI 600 Access Immunoassay Analyzer W/Dual Gantry, distributed nationwide in the US. The recall was initiated on 25 Jun 2025 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-2270-2025
- FDA event ID
- 97162
- Recalling firm
- Beckman Coulter, Chaska, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jun 2025
- FDA classified
- 5 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Jun 2025 | Recall initiated by company | |
| 5 Aug 2025 | Classified by FDA | +41 days |
| 13 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Where it was distributed
Worldwide distribution - US Nationwide.
Questions about this recall
Why was it recalled?
Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.
Which lots are affected?
UDI-DI: 15099590369248; Serial Numbers: 902101
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
5 other products · FDA event 97162This product is part of a recall event; the main page for the event is DxI 800 Access Immunoassay Analyzer W/Dual Gantry recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DxI 800 Access Immunoassay Analyzer W/Dual Gantry recalled | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | DxI 600 Access Immunoassay Analyzer W/Spot recalled by Beckman Coulter | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | DxI 800 Access Immunoassay Analyzer W/Spot recalled by Beckman Coulter | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | UniCel DxI 600 Access Immunoassay Analyzer recalled by Beckman Coulter | Beckman Coulter | Device Malfunction | Nationwide | |
| CLASS II | UniCel DxI 800 Access Immunoassay Analyzer recalled by Beckman Coulter | Beckman Coulter | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
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| 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 |
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| Device | CLASS II | Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled | Biomerieux | Other | MO |
| Device | CLASS II | DASH Rapid PCR Instrument recalled by Nuclein | Nuclein | Device Malfunction | Nationwide |
| Device | CLASS II | STA Staclot Protein recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |