Ortho-Clinical Diagnostics is recalling approximately 6,920 units of VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Packs and Calibrators due to a defect that causes increased calibration failures or falsely elevated test results. These products are used in clinical laboratories to detect and quantify antibodies to the Hepatitis B surface antigen. If a test produces a falsely elevated result, it could lead to an incorrect assessment of a patient's immunity to Hepatitis B. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding this recall.
The defect may result in falsely elevated test values, which could lead healthcare providers to incorrectly believe a patient has developed sufficient immunity to the Hepatitis B virus, potentially resulting in improper patient management or a lack of necessary vaccinations.
Contact healthcare provider or manufacturer
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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