Device product
VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest
Z-1364-2019
Product summary
- Event
- Event 82561
- Status
- Terminated
- Classification
- Class II
- Quantity
- 85 units: US=19;OUS=66
- Official record key
device-enforcement:Z-1364-2019
Official wording
Reason: Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported
Code information: Serial Number 76000108 thru current.
Distribution pattern: Worldwide Distribution - US Nationwide in the states of AZ, CA, IL, OH, FL, TX, MI Foreign: Australia, Belgium, Chile, India, Italy, Japan, South Korea, Spain, Canada,, Phillippines
Derived failure modes
-
Unknown
Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported