Quest International, Inc. is recalling ReQuest Measles IgG (Rubeola IgG Enzyme Linked Immunoabsorbant Assay) diagnostic tests, model 01-190. These kits were distributed without the required FDA premarket approval or clearance, meaning their safety and effectiveness for detecting measles antibodies have not been reviewed by the agency. These tests are intended for laboratory use to identify the presence of antibodies against the measles virus in patient serum or plasma.
Using a diagnostic test that has not been cleared or approved by the FDA carries a risk of providing inaccurate results. This could lead to a misdiagnosis of a patient's immunity or infection status, potentially resulting in improper medical treatment or a failure to implement necessary public health precautions.
Used to detect the presence of IgG antibodies against measles virus in a patient's serum or plasma using the ELISA method.
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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