Recall Z-1321-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1321-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-19

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-01-19, terminated 2015-09-21. It names one FDA 510(k) clearance: K093732. Product: ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.. Reason: Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays which was the result of calibrator value miscalculation..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-01-19
Terminated: 2015-09-21
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K093732 — ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770Siemens Healthcare Diagnostics·cleared 2010-03-22

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

ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2), Phenytoin_2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry systems. System Information: (For Information Only) The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use. The ADVIA Chemistry systems are automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine in random access and batch modes for in vitro diagnostic use.

Reason for recall

Incorrect calibrator lot values were assigned for ADVIA Chemistry Systems Drug Calibrator I, lot 3JD018, for the ADVIA Chemistry Systems Phenytoin 2 (PHNY_2) and Phenobarbital 2 (PHNB_2) assays which was the result of calibrator value miscalculation.

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