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VITROS Chemistry OP Reagent (Ortho-Clinical) – QC Result Concern (2025)

Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.

Moderate

FDAJun 12, 2025Nationwide• Ortho-Clinical Diagnostics, Inc.

Partial Nephrectomy Robotic (AVID Medical) – Visualization System Error (2025)

CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.

Low

FDAJun 11, 2025CA, IL, MD +4 more• AVID Medical, Inc.

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VITROS Chemistry OP Reagent (Ortho-Clinical) – QC Result Concern (2025)

Partial Nephrectomy Robotic (AVID Medical) – Visualization System Error (2025)

Gen Laparoscopy Pack (Avid Medical) – Visualization System Discoloration (2025)

Partial Nephrectomy Pack (Avid Medical) – Visualization System Discoloration (2025)

HSG Procedure Tray (CooperSurgical) – Iodine Pouch Labeling (2025)

Robotic Uro/GYN Pack (AVID Medical) – Visualization System Error (2025)

Laparoscopy Pack (AVID Medical) – Visualization System Error (2025)

GYN Laparoscopy Pack (AVID Medical) – Visualization System Error (2025)

Laparoscopic Prostatectomy (AVID Medical) – Visualization System Error (2025)

CT Da Vinci Kit (Avid Medical) – Visualization System Discoloration (2025)

Laparoscopic GYN (AVID Medical) – Visualization System Error (2025)

Lap Chole Pack (AVID Medical) – Visualization System Error (2025)

Caphosol Artificial Saliva (Recordati) – Stability Test Concern (2025)

Laparoscopic Tray (Avid Medical) – Visualization System Discoloration (2025)

General Robotic Pack (Avid Medical) – Visualization System Discoloration (2025)

Cardiac Robot Pack (Avid Medical) – Visualization System Discoloration (2025)

Endosee Convenience Kit (CooperSurgical) – Iodine Pouch Labeling (2025)

Asprire Cristalle Mammography (Fujifilm) – Unapproved Software (2025)

General Laparoscopy Tray (Avid Medical) – Visualization System Discoloration (2025)

GYN Robotic Pack (AVID Medical) – Visualization System Error (2025)