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VITROS 5600 Integrated System (Ortho-Clinical) – Sample Aspiration Risk (2024)

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

Moderate

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS 3600 Immunodiagnostic System (Ortho-Clinical) – Sample Aspiration Risk (2024)

Moderate

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

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VITROS 5600 Integrated System (Ortho-Clinical) – Sample Aspiration Risk (2024)

VITROS 3600 Immunodiagnostic System (Ortho-Clinical) – Sample Aspiration Risk (2024)

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Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

Cranial Access Kit (Integra) – Packaging Integrity Problem (2024)

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