Class 2 Device Recall VITROS 3600 Immunodiagnostic System

• Date Initiated by Firm: January 26, 2024
• Date Posted: March 01, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1229-2024
• Recall Event ID: 93927
• 510(K)Number: K083173
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
• Code Information: VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002979 Refurbished UD-DI 10758750007103 Serial Numbers: US: J36000109 J36000292 J36000489 J36000955 J36001167 J36001222 J36001283 J36001330 J36001348 OUS: J36000148 J36001000 J36001495 J36000340 J36001012 J36001513 J36000348 J36001024 J36001515 J36000406 J36001026 J36001519 J36000407 J36001027 J36001528 J36000427 J36001051 J36001530 J36000446 J36001088 J36001535 J36000511 J36001108 J36001558 J36000517 J36001111 J36001570 J36000580 J36001112 J36001573 J36000612 J36001117 J36001575 J36000626 J36001154 J36001579 J36000688 J36001229 J36001581 J36000753 J36001237 J36001582 J36000861 J36001245 J36001583 J36000877 J36001246 J36001595 J36000920 J36001401 J36001600 J36000923 J36001403 J36001602 J36000929 J36001427 J36001608 J36000933 J36001451 J36001618 J36000941 J36001488 J36001632 J36000942 J36001489 J36001640
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics, Inc.; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: Mr. Joe Falvo; 585-453-3000
• Manufacturer Reason for Recall: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
• FDA Determined Cause: Software Design Change
• Action: On January 26, 2024, the firm issued a customer letter to all customers who have V3.8.0 or V3.8.1 installed on their VITROS Analyzer. Customers were informed of the issue and instructed to follow the instructions when using the VITROS System onboard QC package to use the configurable Westgard Rules. The software will be updated to mitigate this issue within the VITROS Software QC feature. The estimated availability is 2Q2024. If you have further questions, please contact Global Services Organization at 1-800-421-3311.
• Quantity in Commerce: 9 US; 66 OUS
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, 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.

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