FDAClass IIIAugust 2, 2023

VITROS Immunodiagnostic Products NT-proBNP II Range recall

VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the…

Why was VITROS Immunodiagnostic Products NT-proBNP II Range recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the…
Recalling firm
Ortho-Clinical Diagnostics, Inc.
Quantity
2 units
Distribution
US Nationwide distribution in the state of CA.
Recall date
August 2, 2023
Classification
Class III
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls