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June 5, 2025
05
Jun

FDA Recall: Software update preventing the assay from being performed leading to delayed results

June 5, 2025
Company: Beckman Coulter, Inc. Date of Enforcement Report: 6/5/2025 Class: II PRODUCT DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 Recall Number: Z-1913-2025 REASON: 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...
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