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 concentrations lower than 300 mg/dL, causing digoxin results to be too low. This may lead to incorrect treatment decisions for heart conditions.
Patients using VITROS DGXN Slides for digoxin testing are most at risk. The recall applies to units sold in the last 18 months with specific coating numbers.
Check for model number 8343386 on the slide packaging. The recall covers units sold in the last 18 months with coating numbers 0271 or 0272.
Look for model number 8343386 and coating numbers 0271 or 0272 on the slide packaging.
Hemoglobin in blood samples can cause digoxin test results to be too low at concentrations below 300 mg/dL, potentially leading to incorrect treatment decisions.
The recall does not specify a remedy; check the product details to see if you have affected units.
Check for model number 8343386 and coating numbers 0271 or 0272 on the slide packaging. The recall applies to units sold in the last 18 months.
We’ve drafted a message you can send VITROS to request your refund or repair — edit it as you like.
Subject: Recall Z-0902-2025 — VITROS VITROS Hello, I own a VITROS that is covered by recall Z-0902-2025 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.
