Z-2225-2023Class III

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

Name: Z-2225-2023 VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2023-05-18
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2023-05-18 / Open, Classified / root cause: labeling and UDI

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS... on 2023-05-18. FDA classified it as Class III and gives the reason as "May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2225-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-05-18
Posted: 2023-07-21
Recalling firm: 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
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2225-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2225-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-21

Product code JJX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)