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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 Systemsee related information
Date Initiated by FirmMay 09, 2025
Date PostedJune 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2039-2025
Recall Event ID 96946
510(K)NumberK182063 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductBrand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
Code Information VITROS XT 7600 Integrated System; Product Code: 6844461; UDI: 10758750012343; VITROS XT 7600 System - Certified; Product Code: 6272222; UDI: 10758750012343; Range of installed serial numbers:76000109-76002327; Total systems currently installed in the US: 1,019 Total systems currently installed outside the US: 939 Total systems installed worldwide (Product Quantity Distributed): 1,958 Note1: The catalogue number 6844461 is used to denote the VITROS XT 7600 Integrated System. Catalogue number 6272222 is used to denote VITROS XT 7600 System Certified. A VITROS XT 7600 Integrated System maintains its original serial number through the certification process. Therefore, the manufacturing and distribution information for the two catalogue numbers will be combined. Note2: When manufactured, the system s serial numbers are sequential, but not all analyzers are released for distribution and therefore not installed. The range of serial numbers provided includes the identified minimum and maximum in serial numbers associated with all currently installed systems. Therefore, the amount of each system manufactured may not equal the amount of each system installed. Additionally, not all serial numbers listed are associated with an active installed analyzer in use today.
FEI Number 1000136573
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactJoe Falvo
585-4533452
Manufacturer Reason
for Recall		a software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the Use Expired Reagents setting is not enabled if a shelf expiration date is omitted during manual loading. The issue was identified by a customer complaint, in which a CREA Urine test was processed with an RE (Reagent Expired) code, even though the diluent pack was not expired and the use-expired-reagents setting was disabled. This can result in erroneous test results and/or delaying test results.
FDA Determined
Cause 2		Software design
ActionOn May 22, 2025, "URGENT PRODUCT CORRECTION NOTIFICATION" letters were sent to customers. REQUIRED ACTIONS - To prevent this issue from occurring, the shelf expiration date must be entered when manually loading VITROS Diluent Packs on VITROS 4600/5600/XT 7600 Systems. - View the Reagent Management Supply 3 screen to check for any onboard VITROS Diluent Packs marked as expired. o For all VITROS Diluent Packs marked as expired, navigate to View By Reagent View Dil/ANC and confirm the shelf expiration date matches the shelf expiration date on the product labeling. o If the shelf expiration dates do not match, discard the VITROS Diluent Pack and load a new VITROS Diluent Pack. QuidelOrtho will credit your discarded inventory. (Credit will only be issued for within-expiry products.) - Complete and return the enclosed Confirmation of Receipt form no later than May 30, 2025. Upon receipt of your completed Confirmation of Receipt form, QuidelOrtho will credit or replace your discarded inventory. - Save this notification with your User Documentation or post this notification by each VITROS 4600/5600/XT 7600 System in your laboratory until the issue has been resolved. - Please forward this notification if the affected product was distributed outside of your facility. - If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. Resolution QuidelOrtho has determined root cause, and this issue will be resolved in an upcoming software update. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.
Quantity in Commerce1958 units (1019 US, 939 OUS)
DistributionWorldwide Distribution: US (Nationwide) and OUS (International) to countries of: Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JJE
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