Device product
VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6844458
Z-1675-2022
Product summary
- Event
- Event 90681
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 506 units
- Official record key
device-enforcement:Z-1675-2022
Official wording
Reason: Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Code information: UDI-DI: 10758750031986 Systems start with 3400XXXX where XXXX is unique for each analyzer
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
Derived failure modes
-
Unknown
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.