Beckman Coulter Ireland, Inc. is recalling 34,451 units of its LDL Cholesterol OSR6x96 reagent kits because the product does not meet the performance claims in its instructions. The laboratory reagent can show falsely high cholesterol levels when high concentrations of triglycerides are present in a patient's sample. This recall affects all lots and expiration dates of the test kits used with instructions version BAOSR6X96-10 and prior.
Patients with high triglyceride levels may receive an LDL cholesterol test result that is up to 28.8% higher than their actual level. This could lead to an incorrect medical diagnosis or unnecessary treatments based on inaccurate laboratory data.
All Lots and Expiration Dates are affected. Specifically concerns Instructions for Use (IFU) Version BAOSR6X96-10 and prior.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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