siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method… — Class II medical device recall Z-0148-2015

Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2014-11-05, distributed nationwide. Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot res

Recall number	`Z-0148-2015`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Healthcare Diagnostics, Inc., Newark, DE, United States
Recall initiated	2014-09-24
Classified	2014-10-29
Reported by FDA	2014-11-05
Terminated	2016-08-17
Distributed	Nationwide (US)
Countries outside the US	AU, BR, BS, CA, CL, IN, JP, UY
Quantity	1,733
Reason classes	potency
Lot numbers	`FA5154`
Expiration dates	`2015-06-03`

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.

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0148-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.