Z-0148-2015Class II

siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension clinical chemistry...

Name: Z-0148-2015 siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension clinical chemistry...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2014-09-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2014-09-24 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended to... on 2014-09-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0148-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-24
Posted: 2014-10-29
Terminated: 2016-08-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: DIP Enzyme Immunoassay, Diphenylhydantoin
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Siemens sent an Urgent Medical Device Recall Notification dated September 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed as follows: " Discontinue use and discard any remaining inventory of PTN lot FA5154, and complete the attached form indicating your replacement product needs in the attached Field Correction Effectiveness Form. " Siemens will replace any unused inventory of the affected lot at no charge. We apologize for the inconvenience this situation may have cause. If you have any questions, please contact Siemens Customer Care Center - Technical Solutions at (800) 441-9250, or your local Siemens technical support representative.
Quantity in commerce: 1733
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico., and the countries of Australia, Brazil, Bahamas, Canada, Chile, India, Japan and Uruguay
Product codes and lots: lot FA5154, exp. 2015-06-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0148-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0148-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-29

Product code DIP

K911056Class IIDu Pont Dimension(r) Phenytoin (Ptn) MethodE.I. Dupont DE Nemours & Co., Inc. / cleared 1991-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)