Class 3 Device Recall VITROS Chemistry Products Calibrator Kit 29

• Date Initiated by Firm: May 14, 2024
• Date Posted: July 01, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2245-2024
• Recall Event ID: 94734
• Product Classification: Ferrozine (colorimetric) iron binding capacity - Product Code JMO
• Product: VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent Model/Catalog Number: 6802344
• Code Information: (UDI/GTIN# 10758750002672; Lot Number 2953; Expiration Date: 24-Jul-2024
• FEI Number: 1000136573
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics, Inc.; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Joe Falvo; 585-4533452
• Manufacturer Reason for Recall: Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function appropriately.
• FDA Determined Cause: Labeling design
• Action: QuidelOrtho issued a hardcopy customer letters to Distributors and End-USers (Ref. CL2024-130) via FedEx overnight courier and/ or electronically using ORTHO PLUS e-Communications on 22 May 2024. Letter states reason for recall, health risk and action to take: Discontinue using, render unusable, and discard any remaining inventory of VITROS Chemistry Products Calibrator Kit 29, Lot 2953 by the correct expiration date, 24-Jul-2024. " If you have previously obtained a Certificate of Analysis, then download a new one from ORTHO PLUS on quidelortho.com. " To help assure the product is not supported beyond its expiry date, upload ADD DRV 6286 or higher before 24-Jul-2024. Once DRV 6286 or higher has been uploaded the product will no longer be supported and you must use an alternate lot. " Complete the enclosed Confirmation of Receipt form no later than May 29, 2024. Upon receipt of your completed Confirmation of Receipt form, QuidelOrtho will provide credit or replacement of your existing inventory of VITROS Chemistry Products Calibrator Kit 29, Lot 2953. " Save this notification with your User Documentation or post this notification by each VITROS 5,1 FS/4600/5600/XT 7600 System until the issue has been resolved. " Please forward this notification if the product was distributed outside of your facility. Contact Information. If you have further questions, please contact the Global Services Organization at 1-800-421-3311.
• Quantity in Commerce: 1718
• Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
• 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.