Company: Beckman Coulter, Inc.
Date of Enforcement Report: 6/5/2025
Class: II

PRODUCT

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

Recall Number:

Z-1913-2025

REASON:

A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated and may require field service to resolve the delay.

RECALLING FIRM/MANUFACTURER:

Beckman Coulter, Inc.

VOLUME:

231 units

DISTRIBUTION:

Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain and Northern Irland, Oman, Algeria, Czechia, Korea, Public of, Slovakia, Croatia, Cote d’lvoire, Australia, Ireland, Taiwan, Province of China, New Zealand, Austria, Hungary, Brazil, Israel, Portugal