Beckman Coulter is recalling 2,068 units of Access Total T4 Calibrator (Catalog No. 33805) due to a defect that causes inaccurate, falsely low thyroid test results on certain laboratory instruments. These inaccurate results can lead to unnecessary diagnostic testing, incorrect dosing for pregnant patients, or delayed treatment for hyperthyroidism. While no injuries have been reported, the defect involves specific lots used in medical laboratories and hospitals worldwide.
The calibrator exhibits a negative bias on DxI 600 and 800 instruments, meaning it may produce thyroid hormone readings that are lower than the patient's actual levels. This can result in patients receiving treatment for disorders they do not have or failing to receive necessary treatment for overactive thyroid conditions.
Used on DxI 600/800 instruments.
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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