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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter DxI 9000 Access Immunoassay Analyzer

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 Class 2 Device Recall Beckman Coulter DxI 9000 Access Immunoassay Analyzersee related information
Date Initiated by FirmMarch 05, 2024
Date PostedAugust 30, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1546-2024
Recall Event ID 94191
510(K)NumberK221225 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductDxI 9000 Access Immunoassay Analyzer, REF C11137, 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 Numbers: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282
FEI Number 2122870
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information ContactRachel Davison
408-893-4333
Manufacturer Reason
for Recall		Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.
FDA Determined
Cause 2		Process control
ActionBeckman Coulter notified consignees on 03/05/2024 via FedEx and email. The letter outlined the reason for the recall and requested consignees to review inventory for affected units. If any affected units are identified, to inspect the area underneath the wash buffer drawer for evidence of leaking wash buffer. If leaking or pooling is observed, clean up liquid wearing appropriate Personal Protective Equipment (PPE), discontinue the use of the DxI 9000, and contact your Beckman Coulter representative immediately. If no leaking or pooling of Wash Buffer in observed, continue operating the instrument as normal and continue to monitor for leaking. A Field Service Representative will contact customers to replace the internal wash buffer tank on the affected instruments. Consignees were also instructed to share this information with laboratory staff, notify any customers if further distributed, and complete and return the response form.
Quantity in Commerce17 units
DistributionWorldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.
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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