Medium RiskFDA Device

Ortho-Clinical Diagnostics, Inc.: Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.

Agency Publication Date: September 2, 2022

Affected Products

Product: VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458

UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer

Product: VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

UDI-DI: 10758750031610 Systems start with 7600XXXX where XXXX is unique for each analyzer

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90681

Status: Active

Manufacturer: Ortho-Clinical Diagnostics, Inc.

Manufactured In: United States

Units Affected: 2 products (506 units; 1148 units)

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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.

Affected Products

Product: VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458

UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer

Product: VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461

UDI-DI: 10758750031610 Systems start with 7600XXXX where XXXX is unique for each analyzer