Z-1664-2025Class II

Beckman Coulter DxI 9000 Access Immunoassay Analyzer

Name: Z-1664-2025 Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Creator: Beckman Coulter, Inc.
Published: 2025-03-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-03-27 / Open, Classified / root cause: software

FDA source

Beckman Coulter, Inc. began a recall of Beckman Coulter DxI 9000 Access Immunoassay Analyzer on 2025-03-27. FDA classified it as Class II and gives the reason as "When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose...". 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-1664-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-27
Posted: 2025-04-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter DxI 9000 Access Immunoassay Analyzer
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose communication with the host system. The lost connection interrupts sample processing, which delays reporting patient test results and may subsequently delay patient treatment.
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 03/27/2025 via USPS first class mail. The notice explained the issue with the device, impact to the patient, and provided a workaround until a software upgrade is available. If the consignee further distributed the affected device, they were directed to provide a copy of the notice to the recipient. For questions, contact Customer Support Center, from the website: http://www.beckmancoulter.com
Quantity in commerce: 370 units
Distribution: Worldwide distribution.
Product codes and lots: UDI/DI 15099590732103, all units run with system software versions SW 1.20.0 and below

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1664-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1664-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-24

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)