VITROS 3600 Diagnostic System May Fail to Alert Users to Expired Reagents
The VITROS 3600 Immunodiagnostic System may not properly alert users when Signal Reagent Packs expire, risking use of expired products and potentially inaccurate test results. Affected systems worldwide should be checked for this software issue.
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: FDA Class II recall of a medical diagnostic device. The failure to alert users to expired reagents qualifies as a risk-of-harm situation in which no injuries or illnesses have been reported, placing this in the High severity category.
Plain-English summary
The VITROS 3600 Immunodiagnostic System, manufactured by Ortho-Clinical Diagnostics, Inc., is subject to recall due to a software defect. The system's software version 3.8.0 and higher may fail to notify users when Signal Reagent Packs exceed their on-board or shelf-life expiration dates.
This notification failure could result in the continued use of expired reagent products. Use of expired reagents may produce no results or erroneous results from the instrument, compromising the accuracy of laboratory diagnostic testing.
The recall affects 981 total units currently installed worldwide, including 99 units in the United States and 882 units outside the United States. The affected systems have serial numbers ranging from 36000004 to 36001776, manufactured and distributed from June 2008 to present.
Users of the VITROS 3600 system should verify that their software alerts them to reagent expiration dates and check all Signal Reagent Packs for expiration before use.
The recalled product
- Product
- Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter pr
- Manufacturer
- Ortho-Clinical Diagnostics, INc.
- Hazard
- expired-reagent
- erroneous-results
- no-results
Distribution
Distributed nationwide across the United States.
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