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Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Recalled June 18, 2025 · FDA recall Z-1926-2025 · Beckman Coulter
Hazard
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation 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
324 units
Sold at
Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries of: Italy, Germany, Spain, New Zealand, France, Australia, Slovakia, Switzerland, Ireland, Brazil, Taiwan, Province of China, India, United Kingdom of Great Britain and Northern Ireland, Hungary, Austria, Portugal, Croatia, Kazakhstan, Cote d'lvoire, Poland, Korea, Republic of, Czechia, Algeria, Libya, Oman, Singapore, and Belgium.
Description
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation 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 versions 1.20
Manufacturer(s)
Beckman Coulter, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →