Ortho-Clinical Diagnostics, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023
Products Sold
UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For due to May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026