Z-2544-2024Class II

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137

Name: Z-2544-2024 Beckman Coulter 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 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137 on 2024-05-22. FDA classified it as Class II and gives the reason as "The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below...". 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-2544-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-22
Posted: 2024-08-09
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below; and a sample tube is sent from the LAS to DxI 9000 Access Immunoassay Analyzer, an out of sequence message will be sent from the Analyzer to the LAS. This issue may result in multiple error messages (i.e., a sample pick and place (PnP) error or a no result obtained (NRT) flag may be displayed) and subsequently a risk of delays in processing/reporting patient test results and 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 mail and email. The letter provided the issue, impact, and actions to take. The actions included: (1) If the issue occurs, initialize the system as prompted by the analyzer; (2) Contact the Beckman Coulter representative and schedule a service visit if the laboratory has experienced sample PnP or aliquot pipettor error that is not resolved by initializing the system; (3) If samples received an NRT flag, request the test again and reload the sample; (4) Identify any sample tubes that were not processed and reload them on the Dxl 9000 Access Immunoassay Analyzer from the sample handler input area. The letter informs the consignee that Beckman Coulter has identified the root cause of the issue and will implement the correction with a future software release. Beckman Coulter will contact the consignee to schedule the software upgrade when it is available.
Quantity in commerce: 183 devices
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, FL, GA, IN, KS, ME, NH, NJ, OK, PA, and TX. The countries of Australia, Austria, Bahrain, Belgium, Brazil, Croatia, Czech Republic, Egypt, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.
Product codes and lots: Software versions 1.17 and below, UDI-DI 15099590732103.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2544-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2544-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-21	2024-08-09

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)