Z-0107-2024Class II

DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic

Name: Z-0107-2024 DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Creator: Beckman Coulter, Inc.
Published: 2023-09-12
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-09-12 / Open, Classified / root cause: software

FDA source

Beckman Coulter, Inc. began a recall of DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic on 2023-09-12. FDA classified it as Class II and gives the reason as "The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the...". 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-0107-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-12
Posted: 2023-10-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.
Root cause tag: software
FDA root cause: Software design
Action: Beckman Coulter notified its consignees on 09/12/2023 via letter. The notice explained the issue, risk, and consignees were advised to perform a retrospective review of all results that were generated on a DxI 9000 analyzer that is connected to a host system (laboratory information system or middleware). Current customers should perform one of the following: Option 1: Disconnect the DxI 9000 Access Immunoassay Analyzer from the host system. You may continue ordering tests through the analyzer console. Option 2: Prevent the host system from downloading test orders or sending new information updates to the analyzer. Beckman Coulter will release system software version 1.15.2, which prevents reporting an erroneous test result. Test results will still be delayed when the DxI 9000 Access Immunoassay Analyzer may incorrectly identify samples.
Quantity in commerce: 36 units
Distribution: Worldwide - US Nationwide distribution in the state of Florida, and the countries of Croatia, Czechia, France, Germany, Ireland, Italy, Netherlands, New Zealand, South Africa, Spain, Switzerland, United Kingdom of Great Britain and Northern Ireland.
Product codes and lots: UDI/DI 15099590732103, All DxI 9000 Access Immunoassay Analyzer running software version 1.15 or prior

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0107-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0107-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-12

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)