Device product
VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 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-1290-2019
Product summary
- Event
- Event 82311
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28 UNITS
- Official record key
device-enforcement:Z-1290-2019
Official wording
Reason: Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Code information: Serial Numbers: Affects systems that had the Luminometer replaced during a service-repair UDI:10758750007103
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