Quidel Ortho has issued a voluntary recall for 5,958 units of VITROS Chemistry Products DGXN Slides (Model 8343386) because they may produce inaccurately low results for digoxin levels. The defect is caused by hemoglobin interference occurring at lower concentrations than the product's technical specifications claim. Digoxin is a medication used to treat heart failure and heart rhythm issues, and inaccurate test results could lead to incorrect medical treatment or a failure to diagnose a drug overdose. No injuries or incidents have been reported to date.
Interference from hemoglobin can cause digoxin measurements to appear lower than they actually are, potentially leading doctors to increase medication dosages unnecessarily or miss a dangerous digoxin overdose. This 'negative bias' poses a moderate risk to patients whose treatment depends on precise blood monitoring.
Recall #: Z-0901-2025. Quantity: 4,417 units (3,358 US, 1,125 OUS).
Recall #: Z-0902-2025. Quantity: 1,541 units (1,125 US, 416 OUS).
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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