Beckman Coulter recalls LDL Cholesterol reagent OSR6x96 that may show falsely high results due to triglyceride levels up to 1500 mg/dL, affecting cholesterol test accuracy.
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).
Beckman Coulter is recalling its LDL Cholesterol reagent OSR6x96 because it can give falsely high results when triglyceride levels are up to 1500 mg/dL. This could lead to incorrect cholesterol readings, which might affect medical decisions.
The reagent may show falsely high LDL cholesterol levels when triglyceride concentrations reach up to 1500 mg/dL. This can cause up to 28.8% overestimation in low LDL samples and up to 11.02% in high LDL samples, leading to incorrect medical interpretations.
People using this reagent for cholesterol testing at home or in labs may get inaccurate results if triglyceride levels are high. Those with high triglycerides are most at risk of misdiagnosis.
Check for the reagent code OSR6x96 with reference numbers OSR6196/15099590010928 or OSR6296/15099590020361. All lots and expiration dates are affected.
Look for the reference numbers OSR6196/15099590010928 or OSR6296/15099590020361 on the reagent packaging.
The reagent may show falsely high LDL cholesterol levels when triglyceride concentrations reach up to 1500 mg/dL, leading to inaccurate test results.
It can cause up to 28.8% overestimation in low LDL samples and up to 11.02% in high LDL samples, potentially leading to incorrect medical decisions.
No, but you should check the reagent code to confirm if you have the affected version and consider using a different reagent if triglyceride levels are high.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-1135-2026 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-1135-2026 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.
