QuidelOrtho is recalling approximately 21,268 units of VITROS Immunodiagnostic Products Free T3 Reagent Packs and Calibrators because they may produce positively biased (incorrectly high) test results for thyroid function. These diagnostic tools are used in clinical settings to measure triiodothyronine (FT3) levels in human blood samples. The defect involves specific reagent packs used with certain calibrators that can lead to erroneous patient results or delays in medical testing. Consumers should be aware that these products were distributed worldwide, including nationwide in the United States, between approximately April and August 2024.
Incorrectly high test results for thyroid function can lead to misdiagnosis, improper patient management, and unnecessary or delayed clinical assessments. This bias may negatively impact the interpretation of other thyroid function tests, potentially leading to incorrect medical treatments.
Medical Device Correction and Notification
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.
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Sources: FDA iRES · Raw API Response
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