Lower riskMedical device recall · FDA · Published May 27, 2024
Beckman Coulter IGM 4x14 mL R1 R2: Incorrect Lipemia Settings May Cause False Results
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
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📍Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/55020-beckman-coulter-igm-4x14-ml-r1-r2-incorrect-lipemia-settings.
“Beckman Coulter IGM 4x14 mL R1 R2: Incorrect Lipemia Settings May Cause False Results.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/55020-beckman-coulter-igm-4x14-ml-r1-r2-incorrect-lipemia-settings. Based on FDA recall #Z-2428-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2428-2024%22&limit=1).
The FDA announced on May 27, 2024, that Beckman Coulter Inc. is recalling its IGM reagents due to incorrect LIH Influence check settings for Lipemia. This error may cause patient samples to be reported with false low results or high results to report as normal.
How to tell if you have it
Brand: Beckman Coulter
Product: REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2
According to the FDA, the LIH Influence check settings for Lipemia are incorrect. This defect may result in patient samples being reported as false low results or cause a high result to report as normal.
Context
GovInfoNow's records show Beckman Coulter, Inc. has had 132 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 Risk: Erroneous Test Results (July 15, 2026), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 DVD Kit: Incorrect Algorithms May Affect Test Results (June 26, 2026), and Beckman Coulter Access Total T4 Calibrator Recall: False Low Results Risk Incorrect Treatment (March 16, 2026).
How to tell if you have this one
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.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the unique device identifier (UDI) starts with 15099590011598 and the lot number is between 2548 and 2554.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 41 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, WA, WI, WV, WY…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2428-2024 (May 27, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2428-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.