DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids
FDA Recall Z-1529-2025 · Posted 2025-04-04
Recalling FirmBeckman Coulter, Inc.
Recall StatusOpen, Classified
Product CodeJJE
Date Initiated2024-07-12
Product Quantity30 OUS
Reason for Recall
Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.
Firm Action
The firm sent notice of "Urgent Medical Device Recall" to affected consignees (all OUS), dated July 3, 2024. Customers were informed of the potential for barcode read failure error, delay of reporting patient test results, and possibility for a small amount of smoke to be emitted.
Consignees were advised that no action was necessary if their laboratory has not observed any RSM Barcode Read Failure error messages. If you do observe any such error messages, or notice smoking or burning smell coming from the Dxl 9000 analyzer, please contact your Beckman Coulter service representative.
Beckman Coulter will no longer ship these analyzers with the affected ground screw. Your Beckman Coulter service representative will contact you to schedule a part replacement that resolves the issue.
Root Cause
Device Design
Distribution Pattern
OUS (Foreign) distribution to countries of: Australia, Croatia, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Africa, Spain, and United Kingdom of Great Britain and Northern Ireland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.