Class 2 Device Recall VITROS 3600

• Date Initiated by Firm: January 22, 2024
• Date Posted: March 01, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1220-2024
• Recall Event ID: 93892
• 510(K)Number: K083173
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: VITROS 3600 Immunodiagnostic System (New and Refurbished)
• Code Information: Code Information: UDI/DI: (New) 10758750002979, (Refurbished) 10758750007103; Serial Numbers: J36001164 through J36001692 (inclusive).
• 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: Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
• FDA Determined Cause: Component change control
• Action: An URGENT PRODUCT CORRECTION NOTIFICATION letter dated 01/22/24 was sent to customers. REQUIRED ACTIONS: To reduce the risk of unintended sample aspiration, refer to the procedure provided in this notification titled, Temporary TRAY Loading Instructions . QuidelOrtho recognizes that the Temporary TRAY Loading Instructions procedure may not be tenable for all laboratories due to testing volumes. Review your laboratory risk management plan(s) to assess the need for this further mitigation. Acknowledge your understanding of this notification by completing the enclosed Confirmation of Receipt form no later than January 30, 2024. Save this notification with your User Documentation or post this notification by each VITROS 3600/5600/XT 7600 System until this issue has been resolved. If your laboratory has experienced the anomaly described in this notification and you have not already done so, please report the occurrence to your local Global Services Organization (formerly Ortho Care). QuidelOrtho has identified root cause however, our investigation is still ongoing. We are currently working on a Hardware Modification (MOD) to resolve this issue and will communicate again once the MOD or additional information is available. Current estimated availability date of the MOD is 2nd quarter 2024. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.
• Quantity in Commerce: 489 units (46 US, 443 OUS)
• Distribution: Worldwide distribution - US Nationwide and the 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