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Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Recalled June 11, 2025 · FDA recall Z-1913-2025 · Beckman Coulter
Hazard
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. · FDA Class II
Units
231 units
Sold at
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.
Description
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.
Product
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →