Recall Z-2225-2023
Ortho-Clinical Diagnostics, Inc. · initiated May 18, 2023
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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
Codes / lots: UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023
Reason for recall
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2225-2023
- Initiated
- May 18, 2023
- Posted by FDA
- July 21, 2023
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state of CA.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc., Rochester, NY