Beckman Coulter Biomedical GmbH: Medical Device Recall in 2023 - (Recall #: Z-2144-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly

Product Classification:

Class II

Date Initiated: June 2, 2023

Date Posted: July 26, 2023

Recall Number: Z-2144-2023

Event ID: 92484

Reason for Recall:

A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results

Status: Ongoing

Product Quantity: 146 systems

Code Information:

UDI-DI: (01)15099590707118, All DxA serial numbers

Distribution Pattern:

US: AL CA FL IL IN KY MI MN MO NE NJ NV NY OH PA SC TX WI WV OUS: Australia, Belgium, Canada, China, Croatia, Czechia, Egypt, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom,

Voluntary or Mandated:

Voluntary: Firm initiated