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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS XT 7600 Integrated System

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  Class 2 Device Recall VITROS XT 7600 Integrated System see related information
Date Initiated by Firm January 26, 2024
Date Posted March 01, 2024
Recall Status1 Open3, Classified
Recall Number Z-1233-2024
Recall Event ID 93927
510(K)Number K182063  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product VITROS XT 7600 Integrated System, Catalog No. 6844461
Code Information VITROS System Software Versions 3.8.0 or 3.8.1 UDI-DI 10758750031610 Serial Numbers: US: J76000050 J76000878 J76001555 J76000108 J76000905 J76001558 J76000144 J76000909 J76001559 J76000148 J76000922 J76001565 J76000179 J76000930 J76001570 J76000192 J76000968 J76001577 J76000195 J76001106 J76001581 J76000199 J76001171 J76001583 J76000200 J76001172 J76001589 J76000206 J76001206 J76001592 J76000207 J76001207 J76001595 J76000208 J76001218 J76001596 J76000241 J76001230 J76001597 J76000298 J76001231 J76001599 J76000313 J76001232 J76001600 J76000317 J76001234 J76001611 J76000324 J76001235 J76001616 J76000333 J76001239 J76001617 J76000342 J76001260 J76001620 J76000352 J76001263 J76001638 J76000353 J76001270 J76001639 J76000420 J76001274 J76001643 J76000422 J76001292 J76001644 J76000456 J76001293 J76001647 J76000459 J76001294 J76001648 J76000460 J76001331 J76001650 J76000468 J76001340 J76001652 J76000495 J76001351 J76001659 J76000502 J76001357 J76001660 J76000524 J76001370 J76001666 J76000525 J76001376 J76001667 J76000537 J76001383 J76001668 J76000561 J76001384 J76001669 J76000609 J76001385 J76001671 J76000709 J76001392 J76001674 J76000743 J76001404 J76001675 J76000747 J76001406 J76001678 J76000783 J76001516 J76001679 J76000790 J76001517 J76001687 J76000803 J76001518 J76001692 J76000805 J76001519 J76001700 J76000806 J76001520 J76001703 J76000817 J76001535 J76001705 J76000862 J76001540 J76001711 J76000866 J76001549 J76001714 J76000868 J76001552 J76001748 J76000871 J76001553 J76001879 J76000873 OUS: J76000106 J76000976 J76000118 J76000983 J76000211 J76001001 J76000253 J76001027 J76000257 J76001035 J76000265 J76001070 J76000274 J76001074 J76000276 J76001095 J76000278 J76001111 J76000280 J76001121 J76000281 J76001130 J76000284 J76001141 J76000288 J76001142 J76000289 J76001144 J76000290 J76001152 J76000292 J76001155 J76000293 J76001159 J76000370 J76001174 J76000436 J76001183 J76000446 J76001189 J76000447 J76001272 J76000475 J76001273 J76000620 J76001285 J76000628 J76001309 J76000760 J76001314 J76000782 J76001328 J76000807 J76001368 J76000813 J76001377 J76000838 J76001378 J76000845 J76001379 J76000855 J76001396 J76000856 J76001399 J76000888 J76001407 J76000898 J76001408 J76000901 J76001452 J76000973 J76001457 J76001484 J76001547 J76001562 J76001563 J76001673 J76001761
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 142 US; 78 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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