Beckman Coulter recalls specific IGM 4x14 mL R1 and 4x11 mL R2 test kits due to incorrect lipemia settings that may cause patient samples to show false low results or normal results for high results.
LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal
Beckman Coulter is recalling certain IGM 4x14 mL R1 and 4x11 mL R2 test kits because their lipemia settings might cause patient samples to be reported as false low results or cause high results to appear normal. This could lead to incorrect medical diagnoses if the test is used without correction.
The test kits have incorrect settings for detecting lipemia (fatty deposits in blood). This can cause the device to report patient samples as having false low results or incorrectly show normal results for samples that should be high. The issue may lead to inaccurate medical decisions if the test is used without adjustment.
Users of the specific IGM 4x14 mL R1 and 4x11 mL R2 test kits with UDI numbers starting with 15099590011598 and lots 2548 through 2554. Healthcare providers and lab personnel who use these kits are most at risk.
Check the unique device identifier (UDI) on the kit, which starts with 15099590011598. Also look for the lot numbers 2548 through 2554, which expire between June 2024 and October 2025.
Verify the unique device identifier (UDI) starts with 15099590011598 and the lot number is between 2548 and 2554.
The recalled test kits are Beckman Coulter IGM 4x14 mL R1 and 4x11 mL R2 with UDI starting with 15099590011598 and lots 2548 through 2554.
Check the unique device identifier (UDI) on the kit, which starts with 15099590011598, and look for lot numbers 2548 through 2554.
The recall record does not specify a remedy, so no action is required beyond checking if your kit 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-2428-2024 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-2428-2024 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.
