Medical Device Recall: DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Beckman Coulter, Inc. · April 23, 2025
Reason for Recall
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.
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.
States Affected
NATIONWIDE
Quantity Affected
231 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1913-2025
Status: ongoing
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