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U.S. Department of Health and Human Services

Class 2 Device Recall DxI 9000 Access Immunoassay Analyzer

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 Class 2 Device Recall DxI 9000 Access Immunoassay Analyzersee related information
Date Initiated by FirmJuly 12, 2024
Date PostedApril 04, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1529-2025
Recall Event ID 96406
510(K)NumberK221225 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductDxI 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
Code Information UDI-DI 15099590732103 Serial/Lot Numbers: 300116, 300117, 300118, 300123, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300141, 300142, 300143, 300145, 300147, 300148, 300149, 300150, 300151, 300152, 300153, 300154, 300155, and 300156
FEI Number 2122870
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information ContactIan Pilcher
952-448-4848
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionThe 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.
Quantity in Commerce30 OUS
DistributionOUS (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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JJE
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