FDA-Device2025-06-11Class II
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Beckman Coulter, Inc.
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.
Sold states
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.
Affected count
231 units
Manufactured in
1000 Lake Hazeltine Dr, N/A, Chaska, MN, United States
Products
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1913-2025Don't want to check this manually?
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