VITROS Immunodiagnostic Products NT-proBNP II Range… recallZ-2225-2023 · Ortho-Clinical Diagnostics, Inc. · initiated May 18, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).

FDA root cause category: Under Investigation by firm

What the company is doing

Ortho Clinical Diagnostics, Inc. (QuidelOrtho) issued Important Product Correction Notification letter on 5/18/23 via FedEx.. Letter states reason for recall, health risk and action to take: Discontinue using and discard your remaining inventory of VITROS NT-proBNP II Range Verifiers, Lot 0090. Ortho Clinical Diagnostics, Inc. will replace or credit your account. Indicate quantities to be replaced or credited via the Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than May 26, 2023. " Please forward this notification if the affected product was distributed outside of your facility. " Save this notification with your user documentation or post this notification by each VITROS ECi/ECiQ/3600/5600/XT 7600 System until the issue has been resolved. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Ortho Care" Technical Solutions Center. Contact Information: Ortho Care Technical Solutions Center at 1-800-421-3311.

Recall details

Recall number: Z-2225-2023
Status: Open, Classified
Initiated by the company: May 18, 2023
Posted by the FDA: Jul 21, 2023
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Quantity: 2 units
Product code: JJX
Distribution: US Nationwide distribution in the state of CA.

Product description

VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090

Code information (models, lots, serial numbers)

UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

VITROS 6192257
Ortho Clinical Diagnostics · Single (specified) analyte controls (assayed and unassayed)
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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