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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter DxI 9000

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 Class 2 Device Recall Beckman Coulter DxI 9000see related information
Date Initiated by FirmMarch 27, 2025
Date PostedApril 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1664-2025
Recall Event ID 96554
510(K)NumberK221225 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductBeckman Coulter DxI 9000 Access Immunoassay Analyzer
Code Information UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below
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		When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
FDA Determined
Cause 2		Software design
ActionBeckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/27/2025 via USPS first class mail. The notice explained the issue with the device, impact to the patient, and provided a workaround until a software upgrade is available. If the consignee further distributed the affected device, they were directed to provide a copy of the notice to the recipient. For questions, contact Customer Support Center, from the website: http://www.beckmancoulter.com
Quantity in Commerce370 units
DistributionWorldwide distribution.
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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