Class 2 Device Recall Ortho Clinical Diagnostics VITROS 5600 Integrated System

• Date Initiated by Firm: May 20, 2020
• Create Date: July 01, 2020
• Recall Status: Terminated on November 16, 2022
• Recall Number: Z-2482-2020
• Recall Event ID: 85762
• 510(K)Number: K083173
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
• Code Information: Affected Serial Number Range : J56000114- J56001879
• FEI Number: 1000136573
• Recalling Firm/ Manufacturer: Ortho Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: SAME; 585-453-3000
• Manufacturer Reason for Recall: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
• FDA Determined Cause: Under Investigation by firm
• Action: Ortho Clinical Diagnostics issued on 20 May 2020, Customer letter (Ref. CL2020-126) sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) to all VITROS 3600, 5600 and XT7600 . Letter states reason for recall, health risk, and action to take: In the meantime, manually adding the values in both the serum screen AND the plasma screen (even though the plasma screen appears to be updated already) will prevent the issue by correctly marking the edits to both body fluids with M1. To manually enter these values for Plasma in Options & Configurations: navigate to Plasma, select the assay, select Review/Edit Configuration , edit Qualitative fields to match Serum. If it appears they currently match, retype at least one of the changes, then touch Save . Once the Qualitative Range values have been updated, load an ADD using Retain Configuration. Verify that both Serum and Plasma values match the intended modifications. This indicates that the modifications were marked with a M1 code and will continue to be retained when that option is used during future ADD loads. " A review of previously reported patient results is recommended if you identify an assay modification in which Serum and Plasma do not match. Review Plasma sample results for these assays versus your intended thresholds. Note: if your VITROS System is connected via e-connectivity, the Ortho Care Technical Solutions Center can assist you with obtaining your patient results from the past 90 days. " If you believe this software anomaly has affected sample results in your laboratory, please contact Ortho Care Technical Solutions Center. " Complete the Confirmation of Receipt form Foreign affiliates were informed by email approximately on 20 May 2020 of the issue and instructed to notify their consignees of the issue and required actions until the software mitigation is available. The anomaly will be resolved with software version
• Quantity in Commerce: 2617 units (U.S.=1272; OUS=1344)
• Distribution: US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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