Device product
Dimension Vista¿ Calcium Flex¿ reagent cartridge, Dimension Vista¿ CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
Z-1540-2018
Product summary
- Event
- Event 79593
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6000
- Official record key
device-enforcement:Z-1540-2018
Official wording
Reason: May produce erroneously low results from specific well sets.
Code information: Lot # 17171BD, UDI # (UDI) 0084276801561817171BD18062010445160 EXP. 06-20-2018
Distribution pattern: Worldwide Distribution - USA (nationwide) and to the following countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia, Slovenia, South Korea, Spain, Switzerland
Derived failure modes
-
Unknown
May produce erroneously low results from specific well sets.