Lower risk Medical device recall · FDA · Published December 8, 2021

Beckman Coulter AU/DxC AU Magnesium Recall: Lipemic Interference Risk

Beckman Coulter recalls AU/DxC AU Magnesium (OSR6189) due to lipemic interference causing inaccurate magnesium results in low magnesium patients. Affected units may show up to 30.38% positive bias in test results.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0692-2022Medical device Beckman Coulter ›

Lower-risk recall

Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia.

Take action

Contact the company

Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232

✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling AU/DxC AU Magnesium test kits because they can give inaccurate magnesium results in patients with low magnesium levels due to lipemia. This could lead to incorrect clinical interpretations of test results. Read more at govinfonow.com/recall/61454-beckman-coulter-au-dxc-au-magnesium-recall-lipemic-interference-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61454-beckman-coulter-au-dxc-au-magnesium-recall-lipemic-interference-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0692-2022

Cite this page

“Beckman Coulter AU/DxC AU Magnesium Recall: Lipemic Interference Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/61454-beckman-coulter-au-dxc-au-magnesium-recall-lipemic-interference-risk. Based on FDA recall #Z-0692-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0692-2022%22&limit=1).

The FDA announced on 2021-12-08 that Beckman Coulter Inc. is recalling AU/DxC AU Magnesium kits due to lipemic interference risks. The agency stated the product may cause positive bias in low magnesium patient samples.

How to tell if you have it

Brand: Beckman Coulter
Product: AU/DxC AU Magnesium
Catalog/REF Number: OSR6189
UDI: 15099590010850
Lot numbers: All lot numbers

The hazard

According to the FDA, lipemic interference for the Magnesium serum application failed to meet performance claims defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is limited to the clinical interpretation of magnesium results in the presence of lipemia.

Context

GovInfoNow's records show Beckman Coulter, Inc. has 133 other recalls on record since 2017-06-20. Other recent recalls of similar products include Beckman Coulter DxC 700 AU Recall: Delay in Results May Cause Diagnosis Delays (2026-01-30) and Beckman Coulter LDL Cholesterol Reagent May Give False High Results (2025-12-08).

How to tell if you have this one

Check for AU/DxC AU Magnesium test kits with Catalog/REF Number OSR6189. All lot numbers are affected, but the specific UDI is 15099590010850.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Test Kit Details
Verify the Catalog/REF Number OSR6189 and UDI 15099590010850 on the test kit.

Where it went and when

Where it was distributed

Distributed in 49 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “US: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, 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, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

Dec 8, 2021Firm started the recall
Feb 28, 2022FDA classified it Class II
Mar 9, 2022Published in FDA’s Enforcement Report
Jan 28, 2025FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Beckman Coulter recalls

Link to this recall

<a href="https://govinfonow.com/recall/61454-beckman-coulter-au-dxc-au-magnesium-recall-lipemic-interference-risk">Beckman Coulter AU/DxC AU Magnesium Recall: Lipemic Interference Risk (GovInfoNow)</a>

Where this comes from

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-0692-2022 (December 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0692-2022 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.