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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS 3600 Immunodiagnostic System

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  Class 2 Device Recall VITROS 3600 Immunodiagnostic System see related information
Date Initiated by Firm January 26, 2024
Date Posted March 01, 2024
Recall Status1 Open3, Classified
Recall Number Z-1224-2024
Recall Event ID 93925
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 Version 3.8.1 Regular UDI-DI 10758750002979 Refurbished UD-DI 10758750007103 Serial Numbers US: J36001167 OUS: J36000427 J36001117 J36001558 J36000580 J36001154 J36001570 J36000626 J36001229 J36001573 J36000688 J36001427 J36001575 J36000877 J36001451 J36001579 J36000920 J36001488 J36001582 J36000929 J36001489 J36001583 J36000942 J36001495 J36001595 J36001012 J36001519 J36001602 J36001051 J36001528 J36001608 J36001108 J36001530 J36001632 J36001111 J36001535 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 3.8.1 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 1 US; 36 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
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