DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Summary
The FDA issued a Class II for DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 by Beckman Coulter, Inc.. Reason: 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.
Details
Source
Device Recall
External ID
Z-2270-2025
Action Date
2025-08-13
Status
Ongoing
Category
device
Product Description
DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461
Lot/Code Info: UDI-DI: 15099590369248; Serial Numbers: 902101
Quantity Affected: 1 system
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.
Distribution
Worldwide distribution - US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-25
Company
Chaska, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 172 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter, Inc. have FDA actions?
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2270-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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