VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only…

Date

Aug. 2, 2023

Risk class

Class III (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences)

Status

Ongoing

Filed by

Ortho-Clinical Diagnostics, Inc.

Product

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

Reason

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

Distribution pattern

US Nationwide distribution in the state of CA.

Quantity

2 units

Codes and lots

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

Recall started

May 18, 2023

Device type

Single (Specified) Analyte Controls (Assayed And Unassayed)

Root cause (FDA)

Under Investigation by firm

What the company told customers

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 number

Z-2225-2023

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2225-2023. The agency record governs; check it and the company before acting.