Quest International, Inc. is recalling 376 units of its ReQuest Measles IgM Test Kits (also known as ELISA Rubeola IgM) because the product was distributed without the required FDA premarket approval or clearance. These kits are laboratory tests used to detect measles antibodies in a patient's blood. Laboratory supervisors and healthcare providers should identify if they have any of the affected kits in their inventory and immediately discontinue their use.
Since these kits have not undergone FDA review, their accuracy and reliability for detecting measles have not been established. Inaccurate test results could lead to a delayed or incorrect diagnosis of measles, potentially impacting patient treatment and public health monitoring.
Measles IgM tests performed using ELISA (Enzyme-Linked Immunosorbent Assay) 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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