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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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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Ortho-Clinical Diagnostics, INc.: VITROS ECO2 Slides Recalled for Potential Incorrect Carbon Dioxide Results

Agency Publication Date: December 7, 2023
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Summary

Approximately 622 units of VITROS Chemistry Products ECO2 Slides are being recalled due to a manufacturing defect in specific lots that can cause the slides to malfunction. These affected slides may produce incorrectly high or low carbon dioxide (CO2) test results for patients, which can lead to misdiagnosis and unnecessary medical treatments. This recall affects various clinical laboratories and healthcare facilities across the country that use VITROS chemistry analysis systems.

Risk

The defect can cause biased CO2 readings, leading healthcare providers to incorrectly diagnose conditions like acidosis or alkalosis. This may result in patients receiving unnecessary intravenous fluids, bicarbonate, or electrolyte replacements, or conversely, a failure to provide life-saving treatment for a serious acid-base imbalance.

What You Should Do

  1. Identify if your facility uses VITROS Chemistry Products ECO2 Slides by checking the packaging for Product Code 8262396 and UDI-DI 10758750004645.
  2. Check your inventory for the following affected lot numbers and expiration dates: 5732-3598-4649 (Exp: 01-Feb-2025), 5732-3598-4650 (Exp: 01-Feb-2025), 5732-3598-4651 (Exp: 01-Feb-2025), 5732-3598-5102 (Exp: 01-Mar-2025), 5732-3598-5105 (Exp: 01-Mar-2025), and 5732-3598-5189 (Exp: 01-Mar-2025).
  3. Immediately stop using the slides from the affected lots and isolate them to prevent further clinical use.
  4. Contact your healthcare provider or QuidelOrtho (Ortho-Clinical Diagnostics, Inc.) to discuss the defect and arrange for any necessary replacements or further technical instructions.
  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

Manufacturer notification and slide isolation

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

Affected Products

Product: VITROS Chemistry Products ECO2 Slides
Model / REF:
8262396
Lot Numbers:
5732-3598-4649 (Exp: 01-Feb-2025)
5732-3598-4650 (Exp: 01-Feb-2025)
5732-3598-4651 (Exp: 01-Feb-2025)
5732-3598-5102 (Exp: 01-Mar-2025)
5732-3598-5105 (Exp: 01-Mar-2025)
5732-3598-5189 (Exp: 01-Mar-2025)
Date Ranges: 01-Feb-2025, 01-Mar-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93378
Status: Active
Manufacturer: Ortho-Clinical Diagnostics, INc.
Sold By: Clinical laboratories; Hospitals; Healthcare facilities
Manufactured In: United States
Units Affected: 622 units 300 Slides (5 cartridge containing 60 slides)
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.