Device product
VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413
Z-0079-2019
Product summary
- Event
- Event 80959
- Status
- Terminated
- Classification
- Class II
- Quantity
- U.S.= 1255 ex-U.S.= 1504
- Official record key
device-enforcement:Z-0079-2019
Official wording
Reason: Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
Code information: Serial Numbers : J56000024 through J56003300
Distribution pattern: Nationwide Foreign: France, Brazil, Chile, Great Britain, Phillippines, Spain
Derived failure modes
-
Unknown
Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.