Diagnostic Chemistry Analyzer Software Error May Report Erroneous Test Results
A software anomaly in the VITROS XT 7600 System allows test results to be reported using expired reagent packs when shelf expiration dates are omitted during manual entry, 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 with no reported illnesses or injuries. However, the issue affects the core function of a diagnostic analyzer—providing accurate patient test results. The potential for erroneous results and misdiagnosis constitutes a risk-of-harm scenario, meeting the rubric criteria for Score 3 (High).
Plain-English summary
Ortho-Clinical Diagnostics has recalled the VITROS XT 7600 Integrated System, an in vitro diagnostic chemistry analyzer used in clinical laboratories. The recall affects 1,958 units worldwide, including 1,019 in the United States and 939 in international markets.
The software contains an anomaly in versions 3.2 through 3.8.3 that allows test results to be reported using expired Micro Tip and Micro Slide diluent packs even when the 'Use Expired Reagents' setting is disabled. This occurs when shelf expiration dates are omitted during manual loading of reagent information. The issue was discovered when a customer reported a CREA Urine test being flagged with a Reagent Expired code despite the diluent pack being unexpired and the use-expired-reagents setting being off.
This anomaly can result in erroneous test results or delays in test processing, potentially affecting patient care decisions based on diagnostic data.
Healthcare facilities with affected VITROS XT 7600 Integrated Systems should contact Ortho-Clinical Diagnostics for instructions. Users should ensure expiration dates for reagent packs are properly entered in the system and monitor test results for anomalies.
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
- software-anomaly
- erroneous-test-results
- delayed-test-results
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.
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