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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Diagnostic Equipment

Ortho-Clinical Diagnostics, Inc.: VITROS XT ALB-TP Slides Recalled for Debris Causing Incorrect Lab Results

Agency Publication Date: August 16, 2024
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Summary

Ortho-Clinical Diagnostics is recalling approximately 88,253 VITROS XT Chemistry Products ALB-TP Slides because the slides may shed dust and debris during normal use in laboratory analyzers. This debris can contaminate other slides (VITROS Na+ Sodium Slides) processed in the same machine, leading to inaccurate medical test results for sodium levels. The affected slides were distributed nationwide and internationally for use in VITROS XT 3400 and VITROS XT 7600 analyzers.

Risk

The dust and debris can cause falsely high or low sodium measurements, which may lead to incorrect medical diagnoses and treatments for conditions like hypernatremia or hyponatremia, potentially posing a serious health hazard to patients.

What You Should Do

  1. Identify if your laboratory uses VITROS XT Chemistry Products ALB-TP Slides, specifically Model/Catalog Number 6844293.
  2. Check your inventory for products with UDI/GTIN# 10758750031771; all current and expired coatings of this product are affected by this recall.
  3. Immediately follow any technical bulletins or instructions provided by QuidelOrtho regarding the use of these slides in VITROS XT 3400 or VITROS XT 7600 analyzers.
  4. Contact your healthcare provider or QuidelOrtho (Ortho-Clinical Diagnostics, Inc.) at their Rochester, NY office for further instructions regarding affected inventory and potential replacements.
  5. For additional information or to report issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact manufacturer for technical guidance and replacement instructions.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: VITROS XT Chemistry Products ALB-TP Slides
Model / REF:
6844293
UPC Codes:
10758750031771
Lot Numbers:
All current and expired coatings

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94993
Status: Active
Manufacturer: Ortho-Clinical Diagnostics, Inc.
Sold By: Direct to clinical laboratories; Medical device distributors
Manufactured In: United States
Units Affected: 88253 units
Distributed To: Nationwide

Were You Affected by This Recall?

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.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.