Beckman Coulter recalls DxI 9000 Access Immunoassay Analyzers due to calibration errors that could lead to incorrect test results. Affected units include specific serial numbers and models. No immediate action is required but users should verify their device and contact the manufacturer for guidance.
Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or calibrator material lot number. The software is not validating the integrity of each calibrator barcode scanned to ensure they are all from the same calibrator card. This includes all software versions and all DxI 9000 instruments that are currently in the field. This issue does not impact calibrator material with 2D calibrator card barcodes. This may cause a failed calibration curve. The health risk to patients is dependent upon the analytes that could be impacted by the error, to include receiving delayed or erroneous results. The issue was identified by Beckman Coulter while conducting a field action on DxI 9000 Access Immunoassay Analyzers.
Beckman Coulter is recalling certain DxI 9000 Access Immunoassay Analyzers because they may accept calibrator values from multiple cards, causing incorrect test results. This could lead to delayed or erroneous patient results depending on the analyte being tested.
The device may accept calibrator values from multiple calibrator cards when an operator configures a new calibrator lot. This causes the software to not validate each barcode, potentially leading to a failed calibration curve and incorrect test results for certain analytes.
Healthcare professionals using the DxI 9000 Access Immunoassay Analyzer for in-vitro diagnostics are most at risk. Patients may receive inaccurate test results if the device is used improperly.
Check if your device has a serial number starting with 300 and ending with numbers from 300116 to 300306. The device is an in-vitro diagnostic used for blood tests and is sold under the model name DxI 9000 Access Immunoassay Analyzer.
Verify your device's serial number starts with 300 and ends with a number between 300116 and 300306.
Reach out to Beckman Coulter for guidance on whether your device needs correction or additional steps.
No, only specific serial numbers starting with 300 and ending with numbers from 300116 to 300306 are affected.
The device may produce incorrect test results, potentially leading to delayed or erroneous patient results depending on the analyte being tested.
The recall does not specify a fix; users should contact Beckman Coulter for guidance on next steps.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-2264-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2264-2024 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.
