Device product
VITROS XT7600 Integrated System
Z-1222-2024
Product summary
- Event
- Event 93892
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,720 units (834 US, 886 OUS)
- Official record key
device-enforcement:Z-1222-2024
Official wording
Reason: Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Code information: Code Information: UDI/DI: 10758750031610; Serial Numbers: J76000109 through J76001913 (inclusive).
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
Derived failure modes
-
Unknown
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.