Device product
VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Z-1293-2019
Product summary
- Event
- Event 82311
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 units
- Official record key
device-enforcement:Z-1293-2019
Official wording
Reason: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Code information: Serial Numbers: Systems that had the Luminometer component replaced during a service-repair. UDI: 10758750001040
Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden,The Netherlands, and United Kingdom.
Derived failure modes
-
Unknown
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems