Z-1115-2025Class II

Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

Name: Z-1115-2025 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Creator: Beckman Coulter, Inc.
Published: 2024-01-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-01-03 / Completed / root cause: software

FDA source

Beckman Coulter, Inc. began a recall of Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument on 2024-01-03. FDA classified it as Class II and gives the reason as "A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as software.

Recall record

Recall number: Z-1115-2025
Classification: Class II
Status: Completed
Initiated: 2024-01-03
Posted: 2025-02-06
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.
Root cause tag: software
FDA root cause: Software design
Action: A field service engineer was dispatched to the customer site to perform the software update and to replace the PCB TSI-RSI board from 01/03/2024 through 12/26/2024.
Quantity in commerce: 61 units
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brazil, Croatia, France, Germany, Hungary, India, Ireland, Italy, New Zealand, Portugal, Slovakia, Spain, Switzerland, Taiwan, Province of China, United Kingdom of Great Britain and Northern Ireland.
Product codes and lots: UDI/DI 15099590732103, serial numbers: 300208, 300201, 300184, 300185, 300169, 300225, 300175, 300172, 300221, 300209, 300211, 300212, 300213, 300214, 300215, 300210, 300174, 300226, 300204, 300216, 300217, 300170, 300220, 300176, 300188, 300199, 300200, 300177, 300222, 300224, 300173, 300181, 300202, 300191, 300223, 300171, 300186, 300190, 300203, 300178, 300195, 300189, 300198, 300227, 300228, 300168, 300194, 300205, 300206, 300207, 300197, 300218, 300179, 300182, 300192, 300219, 300193, 300183, 300180, 300187, 300196.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1115-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1115-2025	Class II	Completed	Voluntary: Firm initiated	2025-02-12	2025-02-06

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)