Z-1546-2024Class II

DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative...

Name: Z-1546-2024 DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative...
Creator: Beckman Coulter, Inc.
Published: 2024-03-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-03-05 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various... on 2024-03-05. FDA classified it as Class II and gives the reason as "Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1546-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-05
Posted: 2024-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DxI 9000 Access Immunoassay Analyzer, REF C11137, 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: Beckman Coulter manufacturing discovered cracks around a threaded insert on the bottom of the Internal Wash Buffer Tank that is used within the Wash Buffer Supply Drawer on the DxI 9000.This can result in leaking, leading to delays in reporting patient test results, exposure to physical and chemical hazards, and damage to equipment or the environment.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beckman Coulter notified consignees on 03/05/2024 via FedEx and email. The letter outlined the reason for the recall and requested consignees to review inventory for affected units. If any affected units are identified, to inspect the area underneath the wash buffer drawer for evidence of leaking wash buffer. If leaking or pooling is observed, clean up liquid wearing appropriate Personal Protective Equipment (PPE), discontinue the use of the DxI 9000, and contact your Beckman Coulter representative immediately. If no leaking or pooling of Wash Buffer in observed, continue operating the instrument as normal and continue to monitor for leaking. A Field Service Representative will contact customers to replace the internal wash buffer tank on the affected instruments. Consignees were also instructed to share this information with laboratory staff, notify any customers if further distributed, and complete and return the response form.
Quantity in commerce: 17 units
Distribution: Worldwide - US Nationwide distribution in the state of New Hampshire and the countries of Belgium, Egypt, Italy, Poland, Spain.
Product codes and lots: UDI/DI 15099590732103, Serial Numbers: 300254, 300256, 300257, 300258, 300259, 300263, 300264, 300266, 300268, 300269, 300270, 300271, 300272, 300273, 300275, 300281, and 300282

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1546-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1546-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-11	2024-08-30

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)