Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic Recalled by Ortho-Clinical Diagnostics, Inc. Due to May not meet the stability specifications for shelf...

Date: May 18, 2023
Company: Ortho-Clinical Diagnostics, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ortho-Clinical Diagnostics, Inc. directly.

Affected Products

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

Quantity: 2 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. has 62 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report