Z-1529-2025Class II

DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the...

Name: Z-1529-2025 DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the...
Creator: Beckman Coulter, Inc.
Published: 2024-07-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-07-12 / Open, Classified / root cause: design

FDA source

Beckman Coulter, Inc. began a recall of DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative... on 2024-07-12. FDA classified it as Class II and gives the reason as "Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1529-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-12
Posted: 2025-04-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in 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: Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent notice of "Urgent Medical Device Recall" to affected consignees (all OUS), dated July 3, 2024. Customers were informed of the potential for barcode read failure error, delay of reporting patient test results, and possibility for a small amount of smoke to be emitted. Consignees were advised that no action was necessary if their laboratory has not observed any RSM Barcode Read Failure error messages. If you do observe any such error messages, or notice smoking or burning smell coming from the Dxl 9000 analyzer, please contact your Beckman Coulter service representative. Beckman Coulter will no longer ship these analyzers with the affected ground screw. Your Beckman Coulter service representative will contact you to schedule a part replacement that resolves the issue.
Quantity in commerce: 30 OUS
Distribution: OUS (Foreign) distribution to countries of: Australia, Croatia, Czechia, France, Germany, Ireland, Israel, Italy, Netherlands, New Zealand, South Africa, Spain, and United Kingdom of Great Britain and Northern Ireland.
Product codes and lots: UDI-DI 15099590732103 Serial/Lot Numbers: 300116, 300117, 300118, 300123, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300141, 300142, 300143, 300145, 300147, 300148, 300149, 300150, 300151, 300152, 300153, 300154, 300155, and 300156

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1529-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1529-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-04

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)