Class 2 Device Recall Beckman Coulter Dxl 9000 Access Immunoassay Analyzer

• Date Initiated by Firm: November 21, 2023
• Date Posted: February 05, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0982-2024
• Recall Event ID: 93724
• 510(K)Number: K221225
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
• Code Information: UDI/DI 15099590732103, Serial Numbers: 300116, 300117, 300118, 300123, 300127, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300138, 300139, 300137, 300140, 300142, 300141, 300144, 300143, 300145, 300148 300146, 300147, 300149, 300150, 300151, 300152, 300155, 300153, 300154, 300156, 300158, 300160, 300163, 300161, 300162, 300164, 300167, 300170, 300169, 300171, 300168, 300166, 300172, 300176, 300173, 300178, 300181, 300179, 300183, 300182, 300188, 300189, 300190, 300191, 300192, 300195, 300196, 300193, 300194, 300197, 300199, 300198, 300201, 300200, 300202, 300203, 300205, 300204 300207, 300206, 300208, 300209, 300212, 300210, 300211, 300213, 300214, 300215, 300217, 300216, 300220, 300218, 300219, 300221, 300223, 300224, 300222, 300227, 300228, 300229, 300231, 300230, 300235, 300236, 300234, 300237, 300232, 300239, 300233, 300238, 300240, 300243, 300241, 300242, 300247, 300246, 300249, 300253, 300244, 300250, 300252, 300248, 300251, 300256, 300257, 300254, 300258, 300255, 300259, 300260, 300261, 300264, 300263, 300262; running software version 1.16 or prior
• Recalling Firm/ Manufacturer: Beckman Coulter, Inc.; 1000 Lake Hazeltine Dr; Chaska MN 55318-1037
• For Additional Information Contact: Rachel Davison; 714-933-5321
• Manufacturer Reason for Recall: There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or < ) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.
• FDA Determined Cause: Software design
• Action: Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/21/2023 via US mail and email. The notices explained the issues with the devices, the impact on test results, and requested the following actions be taken: Issue 1 - Configure the Access Ultrasensitive Insulin assay to the system default units (¿IU/mL). Refer to the appropriate system manuals for instructions. To manually convert concentrations to SI units (pmol/L), multiply ¿IU/mL by a multiplication factor of 7.0. Issue 2 - If the DxI 9000 Access Immunoassay Analyzer is connected to a host system, you can configure the host system to convert results from the system default units to the desired reporting units. If the DxI 9000 analyzer is not connected to a host system, revert all Access assays to their system default units to be sure the analyzer accurately reports dilution assay test results. Perform a retrospective review of all dilution assay test results that were reported in units other than the system default units. Issue 3 - Discontinue using the calculated result feature on the DxI 9000 user interface. Calculations can be performed manually or at the host system. For assay results that have already been run, if a calculated result of 0 was obtained, perform a retrospective review to ensure none of the assay results contained a > or < result. If any of the assay results contained a > or < then the calculated result interpretation should be corrected to no result . Issue 4 - If a reserve volume order is not run automatically as identified by a sample event notification, reload the sample to complete the ordered test. Alternatively, to ensure reserve volume is aliquoted, on the Menu > System Configuration > Test Menu screen, reenter the assay LIS code to match the assay Test ID shown on screen. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have
• Quantity in Commerce: 128 analyzers
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Croatia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
• 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.