Beckman Coulter, Inc. has recalled approximately 64,009 kits of its Access Total T4 reagent assay, model REF 33800, which is used in medical laboratories for thyroid testing. Four specific lots of the product demonstrated imprecision greater than the 10% allowed specification, which can lead to inaccurate or delayed laboratory results for patients. If you had blood work performed using these specific lots, contact your healthcare provider to discuss if re-testing is necessary.
The reagent kits may produce inconsistent or inaccurate thyroid hormone measurements. This defect could cause a doctor to misdiagnose a patient's thyroid condition or delay a correct diagnosis, potentially leading to inappropriate medical treatment.
manufacturer or healthcare provider Consultation
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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