Recall Z-0148-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-0148-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-24

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2014-09-24, terminated 2016-08-17. It names one FDA 510(k) clearance: K911056. 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: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-09-24
Terminated: 2016-08-17
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K911056 — DU PONT DIMENSION(R) PHENYTOIN (PTN) METHODE.I. Dupont DE Nemours & Co., Inc.·cleared 1991-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.