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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS 5600 Immunodiagnostic System

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  Class 2 Device Recall VITROS 5600 Immunodiagnostic System see related information
Date Initiated by Firm January 26, 2024
Date Posted March 01, 2024
Recall Status1 Open3, Classified
Recall Number Z-1226-2024
Recall Event ID 93925
510(K)Number K081543  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
Code Information VITROS System Software Version 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110 Serial Numbers US: J56001885 J56003484 J56001886 J56003541 J56001910 J56003570 J56002308 J56003583 J56002461 J56003646 J56002474 J56003669 J56002608 J56003670 J56002698 J56004068 J56002704 J56004137 J56003342 J56004174 J56003356 J56004491 J56003377 J56004506 J56003433 J56004549 J56003477 J56004551 J56003478 J56004577 OUS: J56000425 J56002518 J56000512 J56002615 J56000533 J56002625 J56000674 J56002637 J56000680 J56002926 J56000719 J56002929 J56000809 J56003061 J56000831 J56003260 J56000836 J56003285 J56001051 J56003401 J56001111 J56003464 J56001114 J56003508 J56001208 J56003523 J56001731 J56003538 J56001765 J56004346 J56001826 J56004355 J56001853 J56004415 J56002085 J56004531 J56002116 J56004695
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 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
FDA Determined
Cause 2		 Software Design Change
Action On January 26, 2024, the firm sent a customer letter to all customers who have V3.8.1 installed on their VITROS Analyzer. Customers were informed of this issue and instructed to follow the instructions when using the VITROS System onboard QC package to update the QC baseline. The software will be updated to mitigate both issues 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 30 US: 38 OUS
Distribution Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.
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 and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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