Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461...
FDA Device Recall #Z-1006-2025 — Class II — December 19, 2024
Recall Summary
| Recall Number | Z-1006-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 19, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ortho-Clinical Diagnostics, INc. |
| Location | Rochester, NY |
| Product Type | Devices |
| Quantity | 1,893 units (994 US, 899 OUS) |
Product Description
Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component
Reason for Recall
The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
Distribution Pattern
Worldwide distribution - US Nationwide and the 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.
Lot / Code Information
Lot Code: VITROS XT 7600 Integrated System Product Code: 6844461 (New) UDI: 10758750012343 VITROS XT 7600 System (Certified) Product Code: 6272222 UDI: 10758750012343 Lot Code: VITROS XT 7600 Integrated System Product Code: 6904003 (China) UDI: 10758750035809 Range of installed serial numbers:76000001-76002199 Manufacture date range: July 2018 to present Distribution date range; July 2018 to present Total systems currently installed in the US: 994 Total systems currently installed outside the US: 899 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. Note3: The value given for "Product Quantity Distributed" is the total number of active installed systems that are in use today. This number is known to fluctuate as individual systems are installed and/or decommissioned.
Other Recalls from Ortho-Clinical Diagnostics, INc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2559-2025 | Class II | Chemistry Products LAC Slides. Catalog Number: ... | Jul 29, 2025 |
| Z-2560-2025 | Class II | VITROS Chemistry Products LAC Slides. Catalog N... | Jul 29, 2025 |
| Z-2335-2025 | Class II | VITROS Chemistry Products Ca Slides; Catalog N... | Jul 9, 2025 |
| Z-2073-2025 | Class II | VITROS Chemistry Products OP Reagent Gen 15. Mo... | Jun 12, 2025 |
| Z-2121-2025 | Class II | Brand Name: VITROS Chemistry Products Product ... | Jun 10, 2025 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.