Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenobarbital_2 (PHNB_2),…

Recall date

January 19, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1321-2015

FDA classification

Class II

Brand / firm

Siemens Healthcare Diagnostics, Inc.

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.