FDA-Device2025-06-18Class II
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Beckman Coulter, Inc.
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.
Sold states
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.
Affected count
324 units
Manufactured in
1000 Lake Hazeltine Dr, Chaska, MN, United States
Products
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1926-2025Don't want to check this manually?
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