Z-2264-2024Class II

DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic

Name: Z-2264-2024 DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Creator: Beckman Coulter, Inc.
Published: 2024-04-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-04-18 / Open, Classified / root cause: software

FDA source

Beckman Coulter, Inc. began a recall of DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic on 2024-04-18. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2264-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-18
Posted: 2024-07-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or calibrator material lot number. The software is not validating the integrity of each calibrator barcode scanned to ensure they are all from the same calibrator card. This includes all software versions and all DxI 9000 instruments that are currently in the field. This issue does not impact calibrator material with 2D calibrator card barcodes. This may cause a failed calibration curve. The health risk to patients is dependent upon the analytes that could be impacted by the error, to include receiving delayed or erroneous results. The issue was identified by Beckman Coulter while conducting a field action on DxI 9000 Access Immunoassay Analyzers.
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 04/18/2024 via USPS first class mail. The notice explained the issue, impact, and requested the following actions be taken: "x Confirm that the DxI 9000 Access Immunoassay Analyzer test name printed on the calibrator card matches the calibrator material name before you configure the calibrator lot. x Scan each individual calibrator card and complete each step displayed on the DxI 9000 Access Immunoassay Analyzer user interface before you scan the next calibrator card. x Review the expected values column on the calibration summary details page and confirm that values for that assay match the values printed on the calibration card. If a calibrator lot had incorrect calibrator levels configured take the following steps: x Delete the impacted calibrator lot: Select Menu > Calibration Material List, select the desired calibration lot, and select Delete. x Reconfigure the correct calibrator lot as described in the Calibration section of the Instructions for Use (IFU). x Rerun the calibration." "Your Beckman Coulter service representative will contact you to schedule the software upgrade when it is available. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter."
Quantity in commerce: 116 units
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI 15099590230623, Serial Numbers: 300116, 300117, 300123, 300124, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300141, 300142, 300143, 300145, 300146, 300147, 300148, 300149, 300150, 300151, 300152, 300153, 300154, 300155, 300156, 300157, 300158, 300160, 300161, 300162, 300163, 300164, 300166, 300167, 300168, 300169, 300170, 300171, 300172, 300174, 300176, 300178, 300179, 300180, 300181, 300182, 300183, 300188, 300189, 300190, 300191, 300192, 300193, 300194, 300195, 300196, 300197, 300198, 300199, 300200, 300201, 300202, 300203, 300204, 300205, 300206, 300207, 300208, 300209, 300210, 300211, 300212, 300213, 300214, 300215, 300216, 300217, 300218, 300219, 300220, 300221, 300222, 300223, 300224, 300226, 300227, 300228, 300229, 300230, 300231, 300232, 300233, 300234, 300235, 300236, 300237, 300238, 300239, 300240, 300241, 300242, 300243, 300244, 300245, 300246, 300247, 300248, 300249, 300251, 300252, 300253, 300254, 300255, 300256, 300257, 300258, 300259, 300260, 300261, 300263, 300264, 300266, 300269, 300270, 300271, 300272, 300273, 300274, 300275, 300276, 300277, 300279, 300280, 300281, 300282, 300283, 300284, 300285, 300286, 300287, 300288, 300289, 300290, 300291, 300292, 300293, 300294, 300295, 300297, 300298, 300299, 300300, 300301, 300302, 300303, 300304, 300305, and 300306

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2264-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2264-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-07-03

Product code JJE

K221225Class IIAccess TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc. / cleared 2022-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)