Device product
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Z-1220-2024
Product summary
- Event
- Event 93892
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 489 units (46 US, 443 OUS)
- Official record key
device-enforcement:Z-1220-2024
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: (New) 10758750002979, (Refurbished) 10758750007103; Serial Numbers: J36001164 through J36001692 (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.