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.
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.
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.
The test kits can produce up to 30.38% positive bias in low magnesium patient samples when lipemia is present. This means the test might show higher magnesium levels than actually exist, leading to incorrect clinical interpretations.
Users of AU/DxC AU Magnesium test kits for magnesium serum testing are affected. Patients with low magnesium levels and lipemia (fatty blood) are at higher risk of inaccurate results.
Check for AU/DxC AU Magnesium test kits with Catalog/REF Number OSR6189. All lot numbers are affected, but the specific UDI is 15099590010850.
Verify the Catalog/REF Number OSR6189 and UDI 15099590010850 on the test kit.
The test kit can cause up to 30.38% positive bias in low magnesium patient samples when lipemia is present, leading to inaccurate magnesium results.
Lipemia (fatty blood) can cause the test to show higher magnesium levels than actually exist, which may lead to incorrect clinical interpretations.
The recall does not provide a remedy; users should check if they have the affected test kits and contact Beckman Coulter for further guidance.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0692-2022 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0692-2022 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.
