Z-2237-2024Class II

Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for...

Name: Z-2237-2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for...
Creator: Beckman Coulter, Inc.
Published: 2024-02-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-02-29 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used... on 2024-02-29. FDA classified it as Class II and gives the reason as "The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2237-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-29
Posted: 2024-06-28
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SYS flag. The analyzer may enter the Red-system status because of this issue. The analyzer also may not eject RVs, where unbound conjugate could potentially splash up on the sidewall of the RV, not being properly washed away, resulting in an artificially higher signal (RLU). The analyzer may not detect this splashing and continue with normal operation, which can cause false low or high erroneous results. Consequently, the analyzer may cancel in-progress tests. These errors could potentially cause delay reporting patient test results and patient treatments. The degree of the potential health hazard is dependent on the analytes that are potentially delayed, especially those analytes that would be used in the acute setting when treatment decisions are immediate. In this particular recall the highest risk analyte is troponin. Health consequences could include permanent impairment or possibly death if medical treatment decisions are delayed due to a delay in obtaining patient results. The issue was identified by Beckman Coulter Inc. manufacturing staff at their location in Brea California on February 29, 2024, during in-process acceptance inspection activities.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Beckman Coulter issued an Urgent Medical Device Recall notice to its consignees on 05/299/2024 via mail and email. The notice explained the problem with the device, impact to patient and user, and requested the following actions: . Repeat testing should be at the discretion of the laboratory's medical director. . Your Beckman Coulter service representative will contact you to schedule a part replacement for this issue. Contact your Beckman Coulter representative if your laboratory has experienced any PnP errors. For questions regarding this notice, please contact our Customer Support Center: http://www.beckmancoulter.com.
Quantity in commerce: 9 instruments
Distribution: Worldwide - US Nationwide distribution in the state of Indiana and the countries of Italy, Sweden, Ireland, Spain.
Product codes and lots: UDI/DI 15099590732103, Serial Numbers: 300273, 300275, 300276, 300277, 300281, 300282, 300284, 300286, 300297

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2237-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2237-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-10	2024-06-28

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)