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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-1231-2024
Recall Event ID 93927
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 Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110 Serial Numbers: US: J56000116 J56003369 J56000317 J56003373 J56001292 J56003377 J56001523 J56003433 J56001629 J56003477 J56001885 J56003478 J56001886 J56003484 J56001910 J56003496 J56002041 J56003541 J56002159 J56003570 J56002198 J56003578 J56002199 J56003581 J56002201 J56003583 J56002249 J56003632 J56002301 J56003646 J56002308 J56003655 J56002461 J56003668 J56002463 J56003669 J56002466 J56003670 J56002474 J56003672 J56002477 J56003725 J56002500 J56003730 J56002591 J56003752 J56002603 J56003759 J56002607 J56003774 J56002608 J56003911 J56002615 J56004068 J56002698 J56004137 J56002703 J56004174 J56002704 J56004240 J56002722 J56004325 J56002769 J56004326 J56002895 J56004485 J56003035 J56004491 J56003045 J56004498 J56003076 J56004506 J56003113 J56004512 J56003199 J56004549 J56003220 J56004551 J56003287 J56004571 J56003299 J56004577 J56003317 J56004587 J56003330 J56004589 J56003334 J56004604 J56003342 J56004606 J56003356 OUS: J56000190 J56001929 J56000246 J56001944 J56000418 J56001979 J56000425 J56002028 J56000468 J56002064 J56000512 J56002085 J56000533 J56002099 J56000665 J56002116 J56000671 J56002218 J56000674 J56002258 J56000680 J56002300 J56000719 J56002410 J56000809 J56002460 J56000831 J56002518 J56000836 J56002615 J56000910 J56002625 J56000929 J56002637 J56000993 J56002784 J56000994 J56002821 J56001015 J56002862 J56001051 J56002913 J56001097 J56002926 J56001111 J56002929 J56001114 J56002966 J56001140 J56003061 J56001208 J56003162 J56001210 J56003179 J56001237 J56003260 J56001260 J56003285 J56001320 J56003401 J56001355 J56003451 J56001378 J56003464 J56001389 J56003508 J56001469 J56003523 J56001509 J56003538 J56001591 J56003919 J56001631 J56003951 J56001689 J56004078 J56001731 J56004082 J56001733 J56004308 J56001765 J56004309 J56001780 J56004346 J56001793 J56004355 J56001826 J56004414 J56001844 J56004415 J56001853 J56004531 J56001925 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 3.8.0 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 2		 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 91 US; 94 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 and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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