The Recall Desk
HighFDA (Devices)·Z-2039-2025·Announced 2025-07-09

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.
Category
Medical Device — In Vitro Diagnostic Chemistry Analyzer
Hazard

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.

Part of a larger recall action

This product is one of 3 recalled by Ortho-Clinical Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Ortho-Clinical Diagnostics, Inc.

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Same hazard · erroneous test results

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