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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Immunodiagnostic Products NTproBNP II Range Verifiers

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  Class 3 Device Recall VITROS Immunodiagnostic Products NTproBNP II Range Verifiers see related information
Date Initiated by Firm May 18, 2023
Date Posted July 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2225-2023
Recall Event ID 92485
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
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
Code Information UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact SAME
585-453-3000
Manufacturer Reason
for Recall		 May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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