Beckman Coulter recalls SYNCHRON Systems Direct LDL Cholesterol reagent lot M404166 due to potential false high cholesterol results. Affected units may need replacement to ensure accurate blood tests.
Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally and confirmed on August 19, 2025 by Beckman Coulter.
Beckman Coulter is recalling a specific lot of LDL cholesterol reagents because they might give false high results in blood tests. This could lead to incorrect health assessments if used without replacement.
The reagent lot M404166 has a higher chance of producing false high cholesterol results when used in blood tests. This could lead to incorrect health assessments if the reagent is not replaced with a verified batch.
Lab users who purchased the SYNCHRON Systems Direct LDL Cholesterol reagent lot M404166 between August 2025 and November 2025 are affected. Those using the reagent for blood tests may face inaccurate cholesterol readings.
Check for the reagent lot number M404166 on the packaging. The product was sold between August 2025 and November 2025 with an expiration date of November 30, 2025.
Look for the lot number M404166 on the reagent packaging to confirm if it is affected.
If the lot number matches M404166, replace it with a verified batch to ensure accurate blood test results.
Beckman Coulter identified that lot M404166 may generate false high results in blood tests, which could lead to incorrect health assessments.
Check the lot number on the packaging; affected units have lot M404166 and were sold between August 2025 and November 2025.
No, but if you have the affected lot number, replace it with a verified batch to ensure accurate test results.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0441-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0441-2026 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.
