VITROS DGXN Slides (model 8343386) may give inaccurate digoxin test results due to hemoglobin interference. Affected units were sold in the last 18 months. Contact QUIDEL ORTHO for details.
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
VITROS DGXN Slides (model 8343386) may cause digoxin test results to be too low due to hemoglobin interference at concentrations below 300 mg/dL. This could lead to incorrect treatment decisions for heart conditions. The recall affects units sold in the last 18 months.
Hemoglobin in blood samples can interfere with the test at lower concentrations than claimed (below 300 mg/dL), causing digoxin results to be too low. This may lead to incorrect treatment decisions if the test is used for heart conditions.
Patients using VITROS DGXN Slides for digoxin testing are affected. Those with heart conditions requiring digoxin monitoring are most at risk.
Check for model number 8343386 on VITROS DGXN Slides. Units sold in the last 18 months are affected, including those with coating 0271 or 0272.
Look for model number 8343386 on VITROS DGXN Slides.
Reach out to QUIDEL ORTHO for recall details and next steps.
Hemoglobin interference may cause digoxin test results to be too low at concentrations below 300 mg/dL, potentially leading to incorrect treatment decisions.
Check if your slides have model number 8343386 and were sold in the last 18 months. Contact QUIDEL ORTHO for further instructions.
The recall is for potential test inaccuracies, not immediate safety hazards. No specific injuries or deaths have been reported.
We’ve drafted a message you can send VITROS to request your refund or repair — edit it as you like.
Subject: Recall Z-0901-2025 — VITROS VITROS Hello, I own a VITROS that is covered by recall Z-0901-2025 from VITROS. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
