Class 2 Device Recall VITROS Chemistry Products Calibrator Kit 20

• Date Initiated by Firm: May 08, 2023
• Date Posted: July 11, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2129-2023
• Recall Event ID: 92440
• Product Classification: Calibrator, secondary - Product Code JIT
• Product: VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only.; VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.; Product Code: 6801704
• Code Information: UDI-DI: 10758750006687 Lot Code: 2022 Exp. Date :06-Sept-2023
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 1000 Lee Rd; Rochester NY 14606-4250
• For Additional Information Contact: SAME; 585-724-2210
• Manufacturer Reason for Recall: Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.
• FDA Determined Cause: Under Investigation by firm
• Action: QuidelOrtho (formerly Ortho Clinical Diagnostics) issued Urgent product correction Notification on 5/8/23. Letter states reason for recall, health risk and action to take: " Immediately discontinue using and discard your remaining inventory of VITROS Calibrator Kit 20, Lot 2022. QuidelOrtho will replace or credit your account. Indicate quantities to be replaced or credited on the attached Confirmation of Receipt form. " If you do not have an alternative lot of VITROS Calibrator Kit 20, you must discontinue reporting patient results using a Lot 2022 calibration. " Upon receipt of your replacement lot of VITROS Calibrator Kit 20, re-calibrate VITROS Transferrin, C3, C4, IgA, IgG and/or IgM assays on your VITROS System. " Complete the enclosed Confirmation of Receipt form . " Please forward this notification if the affected product was distributed outside of your facility. " Post this notification by your VITROS System(s) or with the user documentation until you receive your replacement order. Resolution Once we receive your completed Confirmation of Receipt form, QuidelOrtho will process your replacement order or credit your account. To provide replacement product for all customers, product allocation may be necessary. Contact Information . If you have further questions, please contact our Ortho Care Technical Solutions Center
• Quantity in Commerce: 2400 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, 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.