Beckman Coulter, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2735-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

Product Classification:

Class II

Date Initiated: May 22, 2024

Date Posted: September 4, 2024

Recall Number: Z-2735-2024

Event ID: 94840

Reason for Recall:

When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.

Status: Ongoing

Product Quantity: 183 analyzers

Code Information:

Software versions 1.17.0 or below, UDI-DI 15099590732103.

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, TX, and WA. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom of Great Britain and Northern Ireland.

Voluntary or Mandated:

Voluntary: Firm initiated