VITROS XT 7600 Chemistry Analyzer Software Anomaly Causing Erroneous Test Results
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated System analyzers due to a software anomaly that can report test results as expired when reagent shelf expiration dates are omitted during manual loading, potentially causing erroneous or delayed test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall affecting in vitro diagnostic test results. The source text does not report any illnesses or injuries, and the hazard is the potential for erroneous or delayed test results from a software anomaly. Per the rubric, high-risk product defects where injury has not yet been reported score 3.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling the VITROS XT 7600 Integrated System (Model/Catalog Numbers 6844461 and 6272222, Software Versions 3.2 through 3.8.3) due to a software anomaly affecting in vitro diagnostic chemistry analysis. The issue allows test results to be reported using expired Micro Tip and Micro Slide diluent packs even when the Use Expired Reagents setting is not enabled, if a shelf expiration date is omitted during manual loading.
The anomaly was identified after a customer reported that a CREA Urine test was processed with an RE (Reagent Expired) code despite the diluent pack not being expired and the use-expired-reagents setting being disabled. This can result in erroneous test results and/or delayed test results.
A total of 1,958 VITROS XT 7600 systems have been distributed worldwide: 1,019 in the United States and 939 internationally to countries including Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and the United Kingdom.
Users should contact Ortho-Clinical Diagnostics for guidance on the software anomaly and any necessary corrective action.
The recalled product
- Product
- Brand 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.
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
- erroneous-test-results
- software-anomaly
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- VITROS XT 7600 Integrated System
- Product Code: 6844461
- UDI: 10758750012343
- VITROS XT 7600 System - Certified
- Product Code: 6272222
- Range of installed serial numbers:76000109-76002327
- Total systems currently installed in the US: 1
- the system s serial numbers are sequential
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22