DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137

FDA device recall Z-1326-2025 · posted 2025-03-12 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

Reason for recall

The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results

Action taken

An IMPORTANT PRODUCT NOTICE letter dated 11/6/24 was sent to customers. Contact your Beckman Coulter representative if your laboratory has experienced wash wheel dispense arm spin mixer motor errors that are not resolved by initializing. See the System Management Chapter section in the DxI 9000 Access Immunoassay Analyzer Instruction for Use (IFU) for steps to initialize the Analyzer. Your Beckman Coulter service representative will contact you to schedule a part replacement that resolves this issue. 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. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. If you have any questions regarding this notice, please contact our Customer Support Center: From our website: http://www.beckmancoulter.com

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

JJE

Quantity affected

245 units

Distribution

US Nationwide. Global Distribution.

Date initiated

2024-11-13

Date posted

2025-03-12

Location

Chaska, MN

Related 510(k) clearances