Z-2267-2025Class II
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
Siemens Healthcare Diagnostics Inc. / initiated 2025-06-25 / Open, Classified / root cause: design
Beckman Coulter, Inc. began a recall of DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2267-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Product
- DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
- Product code
- JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- 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.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- An URGENT MEDICAL DEVICE RECALL notification dated 6/25/25 was sent to customers. ACTION: If your laboratory encounters any of the events described in this letter: " Perform a system initialization to resume normal operation. o If repeated initialization attempts fail, contact Customer Technical Support. " Repeat testing for any cancelled tests. " No action is required if your laboratory has not observed the events listed above ESOLUTION: "A Beckman Coulter representative will schedule the modification installation when it is available. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support: " From our website: http://www.beckmancoulter.com
- Quantity in commerce
- 1 system
- Distribution
- Worldwide distribution - US Nationwide.
- Product codes and lots
- UDI-DI: 15099590369231; Serial Numbers: 608109
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2266-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2267-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2268-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2269-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2270-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2271-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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