Class 2 Device Recall Ortho VITROS XT3400 Systems

• Date Initiated by Firm: July 19, 2022
• Create Date: September 02, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1675-2022
• Recall Event ID: 90681
• 510(K)Number: K182063
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
• Code Information: UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer
• 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: Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
• FDA Determined Cause: Under Investigation by firm
• Action: Ortho CLinical issued Urgent Medical Device Correction letter on 19 July 2022 to consignees who received a VITROS XT3400 or a VITROS XT7600 System notified via (CL2020-176) of the issue and instructed to: " If your VITROS XT 3400 and/or VITROS XT 7600 Systems require a system shutdown, routine Quality Control processing for MicroSlide assays must be performed per your laboratory procedure, prior to processing patient samples, to determine if the anomaly has occurred. " If QC results are outside your established ranges, Ortho recommends performing a second system shutdown and re-processing QC fluids for those assays that were outside your established ranges. If QC results are still outside established ranges following a second system shutdown, contact Ortho Care" Technical Solutions Center for guidance. " Ortho recommends using the same vial of QC fluids (where possible) throughout these steps to determine if the anomaly has occurred. Refer to the control storage and stability documentation for fluid stability guidelines once opened or reconstituted. " Post this notification by each VITROS XT 3400 and/or XT 7600 System until this issue is resolved. Ortho is currently investigating this issue; a follow-up communication will be released once our investigation is complete. " Complete the enclosed Confirmation of Receipt no later than July 26, 2022. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
• Quantity in Commerce: 506 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, 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.

• 510(K) Database: 510(K)s with Product Code = JJE