Z-0025-2025Class II

Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the...

Name: Z-0025-2025 Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the...
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 Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative... on 2024-04-18. FDA classified it as Class II and gives the reason as "When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator...". 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-0025-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-18
Posted: 2024-10-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued letters dated 4/12/2024 on 4/18/2024 via first class mail. The letter described the issue, the impact, and actions to be taken, which included: (a) Verify the calibrator material expiration date before ordering a calibration on the analyzer; (b) Cancel calibration orders after the calibrator lot material expires. Instructions for canceling a calibration order are provided in the device help system or in the Calibration section of the IFU; (c) Repeat any test results generated from a calibration curve that used expired calibrator lot material. The resolution provided was that the firm is investigating the root cause of the issue and will implement the correction with a future software release. A service representative will contact the consignee to schedule the software upgrade when it is available. The letter is to be shared with laboratory staff and retained as part of the laboratory Quality System documentation. If the device has been forwarded to another laboratory, the consignee is to provide a copy of the letter to that laboratory. A Response Form was enclosed for completion and return within 10 days to assure the information has been received.
Quantity in commerce: 164 units
Distribution: Distribution was made to FL, GA, IN, KS, NH, NJ, OK, PA, and TX. There was government distribution but no military distribution. Foreign distribution was made to Australia, Austria, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, and United Kingdom of Great Britain and Northern Ireland.
Product codes and lots: UDI-DI: 15099590230623; U.S. serial numbers: 300284, 300286, 300294, 300266, 300291, 300223, 300260, 300285, 300292, 300195, 300227, 300228, 300205, 300207, 300206, 300182, 300192, and 300234. OUS serial numbers have been requested.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0025-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0025-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-07

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)