Ortho-Clinical Diagnostics, Inc.: VITROS Systems Recalled for Potential Erroneous Test Results

Agency Publication Date: March 1, 2024

Summary

Ortho-Clinical Diagnostics is recalling 3,669 VITROS diagnostic systems, including the VITROS 3600, 5600, and XT 7600 models. These laboratory instruments may incorrectly pull samples from unintended containers during processing, which can lead to incorrect or erroneous medical test results. This recall affects both new and refurbished units distributed globally, with over 1,300 units located in the United States.

Risk

The system may process a sample from the wrong container, potentially causing laboratory errors. These erroneous results could lead to incorrect medical diagnoses or inappropriate treatment decisions for patients.

What You Should Do

Identify if your laboratory system is affected by checking the model and serial number on your device.
For VITROS 3600 Immunodiagnostic Systems, check for serial numbers J36001164 through J36001692 (inclusive).
For VITROS 5600 Integrated Systems, check for serial numbers J56000280, J56000330, J56000415, J56000631, J56000634, J56000721, J56000839, J56000871, J56001088, J56001209, J56001228, J56001265, J56001305, J56001355, J56001834, J56001855, J56001941, J56001998, J56002111, J56002239, J56002476, J56002492, J56002531, J56002561, J56002649, J56002655, J56002658, J56002691, and J36001164 through J36001692.
For VITROS XT7600 Integrated Systems, check for serial numbers J76000109 through J76001913 (inclusive).
Contact Ortho-Clinical Diagnostics or your healthcare provider immediately for further technical instructions and to discuss potential service or software updates.
Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

Other Action

Manufacturer guidance

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

Affected Products

Product: VITROS 3600 Immunodiagnostic System (New and Refurbished)

Model / REF:

VITROS 3600

Lot Numbers:

Serial Numbers: J36001164 through J36001692

Product: VITROS 5600 Integrated System (New and Refurbished)

Model / REF:

VITROS 5600

Lot Numbers:

Serial Numbers: J56000280, J56000330, J56000415, J56000631, J56000634, J56000721, J56000839, J56000871, J56001088, J56001209, J56001228, J56001265, J56001305, J56001355, J56001834, J56001855, J56001941, J56001998, J56002111, J56002239, J56002476, J56002492, J56002531, J56002561, J56002649, J56002655, J56002658, J56002691

Serial Numbers: J36001164 through J36001692

Product: VITROS XT7600 Integrated System

Model / REF:

VITROS XT7600

Lot Numbers:

Serial Numbers: J76000109 through J76001913

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93892

Status: Active

Manufacturer: Ortho-Clinical Diagnostics, Inc.

Sold By: Authorized medical device distributors; Direct sales to laboratories and hospitals

Manufactured In: United States

Units Affected: 3 products (489 units (46 US, 443 OUS); 1460 units (506 US, 954 OUS); 1,720 units (834 US, 886 OUS))

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 · 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.

Summary

What You Should Do

Identify if your laboratory system is affected by checking the model and serial number on your device.

For VITROS 3600 Immunodiagnostic Systems, check for serial numbers J36001164 through J36001692 (inclusive).

For VITROS 5600 Integrated Systems, check for serial numbers J56000280, J56000330, J56000415, J56000631, J56000634, J56000721, J56000839, J56000871, J56001088, J56001209, J56001228, J56001265, J56001305, J56001355, J56001834, J56001855, J56001941, J56001998, J56002111, J56002239, J56002476, J56002492, J56002531, J56002561, J56002649, J56002655, J56002658, J56002691, and J36001164 through J36001692.

For VITROS XT7600 Integrated Systems, check for serial numbers J76000109 through J76001913 (inclusive).

Contact Ortho-Clinical Diagnostics or your healthcare provider immediately for further technical instructions and to discuss potential service or software updates.

Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Affected Products

Product: VITROS 3600 Immunodiagnostic System (New and Refurbished)

Model / REF:

VITROS 3600

Lot Numbers:

Serial Numbers: J36001164 through J36001692

Product: VITROS 5600 Integrated System (New and Refurbished)

Model / REF:

VITROS 5600

Lot Numbers:

Serial Numbers: J36001164 through J36001692

Product: VITROS XT7600 Integrated System

Model / REF:

VITROS XT7600

Lot Numbers:

Serial Numbers: J76000109 through J76001913

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93892

Status: Active

Manufacturer: Ortho-Clinical Diagnostics, Inc.

Sold By: Authorized medical device distributors; Direct sales to laboratories and hospitals

Manufactured In: United States

Units Affected: 3 products (489 units (46 US, 443 OUS); 1460 units (506 US, 954 OUS); 1,720 units (834 US, 886 OUS))

Distributed To: Nationwide