Class 2 Device Recall VITROS 4600 Chemistry System

• Date Initiated by Firm: May 09, 2025
• Date Posted: June 27, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2040-2025
• Recall Event ID: 96946
• 510(K)Number: K031924
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
• Code Information: VITROS 4600 Chemistry System; Product Code: 6802445; UDI: 10758750012343; VITROS 4600 Chemistry System - Refurbished; Product Code: 6900440; UDI: 10758750033201; Range of installed serial numbers:46000111-46001897; Manufacture date range: April 2011 to present Distribution date range; April 2011 to present Total systems currently installed in the US: 135 Total systems currently installed outside the US: 1,127 Total systems installed worldwide (Product Quantity Distributed): 1,262 Note1: The catalogue number 6802445 is used to denote the VITROS 4600 Chemistry System. Catalogue number 6900440 is used to denote VITROS 4600 Chemistry System- refurbished. A VITROS 4600 Chemistry System maintains its original serial number through the refurbishment process. Therefore, the manufacturing and distribution information for the two catalogue numbers will be combined. Note2: When manufactured, the system s serial numbers are sequential, but not all analyzers are released for distribution and therefore not installed. The range of serial numbers provided includes the identified minimum and maximum in serial numbers associated with all currently installed systems. Therefore, the amount of each system manufactured may not equal the amount of each system installed. Additionally, not all serial numbers listed are associated with an active installed analyzer in use today. Note3: The value given for "Product Quantity Distributed" is the total number of active installed systems that are in use today. This number is known to fluctuate as individual systems are installed and/or decommissioned.
• 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: a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
• FDA Determined Cause: Software design
• Action: On May 22, 2025, "URGENT PRODUCT CORRECTION NOTIFICATION" letters were sent to customers. REQUIRED ACTIONS - To prevent this issue from occurring, the shelf expiration date must be entered when manually loading VITROS Diluent Packs on VITROS 4600/5600/XT 7600 Systems. - View the Reagent Management Supply 3 screen to check for any onboard VITROS Diluent Packs marked as expired. o For all VITROS Diluent Packs marked as expired, navigate to View By Reagent View Dil/ANC and confirm the shelf expiration date matches the shelf expiration date on the product labeling. o If the shelf expiration dates do not match, discard the VITROS Diluent Pack and load a new VITROS Diluent Pack. QuidelOrtho will credit your discarded inventory. (Credit will only be issued for within-expiry products.) - Complete and return the enclosed Confirmation of Receipt form no later than May 30, 2025. Upon receipt of your completed Confirmation of Receipt form, QuidelOrtho will credit or replace your discarded inventory. - Save this notification with your User Documentation or post this notification by each VITROS 4600/5600/XT 7600 System in your laboratory until the issue has been resolved. - Please forward this notification if the affected product was distributed outside of your facility. - If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. Resolution QuidelOrtho has determined root cause, and this issue will be resolved in an upcoming software update. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.
• Quantity in Commerce: 1262 units (135 US, 1127 OUS)
• Distribution: Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, 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