Diagnostic analyzer software may fail to alert users to expired reagents
VITROS XT 7600 Integrated System software may not warn users when Signal Reagent Packs expire, risking inaccurate or missing 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 a Class II medical device recall with no reported illnesses or injuries. The software defect creates a risk of patient harm by potentially allowing use of expired reagents, meeting the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The VITROS XT 7600 Integrated System is an in vitro diagnostic chemistry analyzer manufactured by Ortho-Clinical Diagnostics. The device runs software version 3.8.0, which contains a defect: it may not correctly notify operators when the Signal Reagent Pack exceeds its on-board or shelf-life expiration date.
If expired reagents are used despite the missing notification, the analyzer may produce no test results or erroneous results. This could impact clinical care decisions based on inaccurate or absent laboratory data.
The recall affects 1,893 units currently installed worldwide—994 in the United States and 899 outside the U.S. Affected systems include models with catalog numbers 6844461, 6272222, and 6904003, with serial numbers from 76000001 to 76002199, manufactured from July 2018 to present.
Healthcare facilities and laboratories using affected VITROS XT 7600 systems should contact Ortho-Clinical Diagnostics for instructions on how to verify reagent expiration dates and obtain a software update.
The recalled product
- Product
- 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
- Manufacturer
- Ortho-Clinical Diagnostics, INc.
- Hazard
- expired-reagent
- erroneous-results
- test-failure
Distribution
Distributed nationwide across the United States.
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