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  "name": "Brand Name: VITROS Chemistry Products  Product Name: VITROS Chemistry Products DGXN Slides  Model/Catalog Number: 8343386  Software Version: Not Applicable  Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support.      Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose.    VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.    One sales unit contains 5 cartridges.  Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit.  Component: No, not a component",
  "description": "FDA recall Z-0901-2025 — QUIDEL ORTHO is recalling Brand Name: VITROS Chemistry Products  Product Name: VITROS Chemistry Products DGXN Slides  Model/Catalog Number: 8343386  Software Version: Not Applicable  Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support.      Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose.    VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.    One sales unit contains 5 cartridges.  Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit.  Component: No, not a component (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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    "name": "Brand Name: VITROS Chemistry Products  Product Name: VITROS Chemistry Products DGXN Slides  Model/Catalog Number: 8343386  Software Version: Not Applicable  Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support.      Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose.    VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.    One sales unit contains 5 cartridges.  Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit.  Component: No, not a component",
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      "name": "FDA recall Z-0901-2025: QUIDEL ORTHO is recalling Brand Name: VITROS Chemistry Products  Product Name: VITROS Chemistry Products DGXN Slides  Model/Catalog Number: 8343386  Software Version: Not Applicable  Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support.      Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose.    VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.    One sales unit contains 5 cartridges.  Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit.  Component: No, not a component",
      "text": "The FDA logged enforcement record Z-0901-2025: QUIDEL ORTHO is voluntarily recalling Brand Name: VITROS Chemistry Products  Product Name: VITROS Chemistry Products DGXN Slides  Model/Catalog Number: 8343386  Software Version: Not Applicable  Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support.      Digoxin is a widely prescribed cardiac glycoside indicated in the treatment of congestive heart failure and supraventricular arrhythmias. Digoxin measurements are used to monitor patient compliance and therapy, and to diagnose potential overdose.    VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.    One sales unit contains 5 cartridges.  Each cartridge holds 18 slides (equivalent to one test), for 90 slides per sales unit.  Component: No, not a component — reason: Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-12-05. Affected lots/codes: Model No 8343386; UDI/GTIN 10758750004782;  Coating 0271, expiration date; 01-March-2025  The scope of this recall is limited to consignees who received VITROS Chemistry Products DGXN slides in the last 18 months.  This will include in-date lots manufactured from coatings (production formulation) 0271 and/or 0272.  Of the in date product, the latest expiration date is listed for the coating.. A RECORDED FDA enforcement action (occurred=true).",
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      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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            "Value": "Domestic: Nationwide Distribution  International: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom,",
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