Recall Z-0289-2013— Horiba Instruments, Inc dba Horiba Medical

Name: FDA recall Z-0289-2013
Creator: U.S. Food and Drug Administration
Published: 2012-09-14

Class III · Terminated

Class III FDA medical device recall by Horiba Instruments, Inc dba Horiba Medical, initiated 2012-09-14, terminated 2012-11-29. It names one FDA 510(k) clearance: K072115. Product: ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.. Reason: This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay..

Recalling firm: Horiba Instruments, Inc dba Horiba Medical
Classification: Class III
Status: Terminated
Initiated: 2012-09-14
Terminated: 2012-11-29
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K072115 — ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/HHoriba Abx·cleared 2007-11-30

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

ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.

Reason for recall

This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay.

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