Device product
siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.
Z-0148-2015
Product summary
- Event
- Event 69372
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1733
- Official record key
device-enforcement:Z-0148-2015
Official wording
Reason: Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range.
Code information: lot FA5154, exp. 2015-06-03
Distribution pattern: Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of Australia, Brazil, Bahamas, Canada, Chile, India, Japan and Uruguay
Derived failure modes
-
Unknown
Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range.