—#205316

Product

DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K221225
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-11-21
Posted by FDA: 2024-02-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205316. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.