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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 Analyzer see related information
Date Initiated by Firm September 12, 2023
Date Posted October 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-0107-2024
Recall Event ID 93023
510(K)Number K221225  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Code Information UDI/DI 15099590732103, All DxI 9000 Access Immunoassay Analyzer running software version 1.15 or prior
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information Contact Adam Viitala
714-993-5321
Manufacturer Reason
for Recall		 The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.
FDA Determined
Cause 2		 Software design
Action Beckman Coulter notified its consignees on 09/12/2023 via letter. The notice explained the issue, risk, and consignees were advised to perform a retrospective review of all results that were generated on a DxI 9000 analyzer that is connected to a host system (laboratory information system or middleware). Current customers should perform one of the following: Option 1: Disconnect the DxI 9000 Access Immunoassay Analyzer from the host system. You may continue ordering tests through the analyzer console. Option 2: Prevent the host system from downloading test orders or sending new information updates to the analyzer. Beckman Coulter will release system software version 1.15.2, which prevents reporting an erroneous test result. Test results will still be delayed when the DxI 9000 Access Immunoassay Analyzer may incorrectly identify samples.
Quantity in Commerce 36 units
Distribution Worldwide - US Nationwide distribution in the state of Florida, and the countries of Croatia, Czechia, France, Germany, Ireland, Italy, Netherlands, New Zealand, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JJE and Original Applicant = Beckman Coulter, Inc.
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