FDAFDA · Food and drugs·Recall number Z-0148-2015
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.
Published November 5, 2014 · Recall initiated: September 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of Australia, Brazil, Bahamas, Canada, Chile, India, Japan and Uruguay
- Lot
- lot FA5154, exp. 2015-06-03
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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