Z-2735-2024Class II

DxI 9000 Access Immunoassay Analyzer, Catalog #C11137

Name: Z-2735-2024 DxI 9000 Access Immunoassay Analyzer, Catalog #C11137
Creator: Beckman Coulter, Inc.
Published: 2024-05-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-05-22 / Open, Classified / root cause: software

FDA source

Beckman Coulter, Inc. began a recall of DxI 9000 Access Immunoassay Analyzer, Catalog #C11137 on 2024-05-22. FDA classified it as Class II and gives the reason as "When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when...". 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-2735-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-22
Posted: 2024-08-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: When a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS) and is running with the system software versions 1.17.0 and below, the analyzer does not send a message to the LAS when the sample wheel is full, and the LAS continues sending samples despite the limited capacity to process new samples. Therefore, sample tests may be aliquoted but not processed when the number of tests associated with onboard patient samples exceeds the throughput limit. If this issue occurs test results are flagged with a sample wheel timeout (SWT) error flag, and there may be a delay in reporting test results which could lead to a delay in patient treatment.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued letters dated 5/16/2024 on 5/22/2024 via postal mail and email notification. The letter described the issue, impact, action, and resolution. Beckman Coulter will implement the correction with a future software release and the consignee will be contacted by their Beckman Coulter service representative to schedule the software upgrade. If the device has been forwarded to another laboratory, the consignee is requested to provide a copy of the letter to that location. A response was requested within 10 days electronically via email or through completion and return of the enclosed Response Form.
Quantity in commerce: 183 analyzers
Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, TX, and WA. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czechia, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom of Great Britain and Northern Ireland.
Product codes and lots: Software versions 1.17.0 or below, UDI-DI 15099590732103.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2735-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2735-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-04	2024-08-27

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)