Beckman Coulter, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1115-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

Product Classification:

Class II

Date Initiated: January 3, 2024

Date Posted: February 12, 2025

Recall Number: Z-1115-2025

Event ID: 96103

Reason for Recall:

A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.

Status: Completed

Product Quantity: 61 units

Code Information:

UDI/DI 15099590732103, serial numbers: 300208, 300201, 300184, 300185, 300169, 300225, 300175, 300172, 300221, 300209, 300211, 300212, 300213, 300214, 300215, 300210, 300174, 300226, 300204, 300216, 300217, 300170, 300220, 300176, 300188, 300199, 300200, 300177, 300222, 300224, 300173, 300181, 300202, 300191, 300223, 300171, 300186, 300190, 300203, 300178, 300195, 300189, 300198, 300227, 300228, 300168, 300194, 300205, 300206, 300207, 300197, 300218, 300179, 300182, 300192, 300219, 300193, 300183, 300180, 300187, 300196.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland.

Voluntary or Mandated:

Voluntary: Firm initiated