Siemens Healthcare Diagnostics, Inc. 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Siemens Healthcare Diagnostics, Inc.
Lot Codes / Batch Numbers
lot FA5154, exp. 2015-06-03
Products Sold
lot FA5154, exp. 2015-06-03
Siemens Healthcare Diagnostics, Inc. is recalling siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinic due to 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 o. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026