Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzer due to pneumatic tubing disconnecting during use, potentially causing false test results and delayed critical treatments like troponin tests.
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.
Beckman Coulter is recalling its DxI 9000 Access Immunoassay Analyzer because pneumatic tubing can disconnect during normal operation. This may cause false test results, delayed patient treatments, and serious health risks if critical tests like troponin are affected.
The pneumatic tubing can fully or partially disconnect during normal operation, causing the analyzer to generate error messages and cancel tests. This may lead to false results or delayed critical treatments, particularly for analytes like troponin where immediate medical action is required.
Healthcare facilities using the DxI 9000 analyzer for clinical testing are most at risk, especially those handling critical analytes like troponin where delayed results could impact immediate treatment decisions.
The DxI 9000 Access Immunoassay Analyzer with UDI/DI 15099590732103 and serial numbers 300273, 300275, 300276, 300277, 300281, 300282, 300284, 300286, 300297.
Look for System Event log messages indicating PnP errors or canceled tests with a SYS flag.
Confirm if your analyzer has the listed serial numbers: 300273, 300275, 300276, 300277, 300281, 300282, 300284, 300286, 300297.
The pneumatic tubing can disconnect during normal operation, causing false test results and delayed critical treatments, especially for analytes like troponin where immediate medical action is needed.
The analyzer may cancel tests, leading to false results or delayed patient treatments, which could cause serious health consequences if critical tests like troponin are affected.
The recall record does not specify a remedy; the manufacturer identified the issue during in-process acceptance inspections but no fix is mentioned.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2237-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2237-2024 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
