Beckman Coulter recalls DxC 500 AU Clinical Chemistry Analyzers with specific catalog numbers and software versions due to incorrect sample barcode identification causing erroneous test results.
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
Beckman Coulter is recalling DxC 500 AU Clinical Chemistry Analyzers that may report incorrect or delayed test results because of barcode identification errors. This could lead to inaccurate medical testing if the device is used without proper correction.
The device may misidentify sample barcodes, leading to incorrect or delayed test results. This error can cause inaccurate medical diagnoses if the analyzer is used without proper correction.
Healthcare facilities using the DxC 500 AU Clinical Chemistry Analyzer with specific catalog numbers and software versions are affected. Laboratory staff and medical professionals who use this device for in vitro diagnostics are most at risk of inaccurate test results.
Check for catalog numbers C63519 or C63520 with specific UDI codes and serial numbers listed in the recall notice. The device also has software versions V1.3 through V1.4.3.
Verify the software version on your DxC 500 AU Clinical Chemistry Analyzer to ensure it is not V1.3, V1.4, V1.4.1, V1.4.2, or V1.4.3.
Check the serial numbers against the list provided in the recall notice to confirm if your device is affected.
Beckman Coulter is recalling the DxC 500 AU Clinical Chemistry Analyzer due to incorrect sample barcode identification and processing errors that can result in erroneous and delayed test results.
Software versions V1.3, V1.4, V1.4.1, V1.4.2, and V1.4.3 are affected by this recall.
Check your device's catalog number and serial numbers against the specific list provided in the recall notice to determine if it is affected.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1672-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1672-2025 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.
