Beckman Coulter, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2544-2024)

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:

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.

Product Classification:

Class II

Date Initiated: May 22, 2024

Date Posted: August 21, 2024

Recall Number: Z-2544-2024

Event ID: 94841

Reason for Recall:

The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and patient treatment.

Status: Ongoing

Product Quantity: 183 devices

Code Information:

Software versions 1.17 and below, UDI-DI 15099590732103.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated