Beckman Coulter, Inc. 2025-08-13 Health serious FDA
Health · FDA · Recall #FDA-Z-2267-2025
DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 Recall
Issued August 13, 2025 · Beckman Coulter, Inc.
In August 2025, Beckman Coulter, Inc. recalled the DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Beckman Coulter, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Beckman Coulter, Inc.
- Category
- Health
- Recall date
- August 13, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide.
- Recall number
- FDA-Z-2267-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Beckman Coulter, Inc. has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.