Class 3 Device Recall ABX PENTRA Creatinine 120 CP

• Date Initiated by Firm: September 14, 2012
• Date Posted: November 14, 2012
• Recall Status: Terminated on November 29, 2012
• Recall Number: Z-0289-2013
• Recall Event ID: 63536
• 510(K)Number: K072115
• Product Classification: Alkaline picrate, colorimetry, creatinine - Product Code CGX
• 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.
• Code Information: Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.
• Recalling Firm/ Manufacturer: Horiba Instruments, Inc dba Horiba Medical; 34 Bunsen; Irvine CA 92618-4210
• For Additional Information Contact: 949-453-0500 Ext. 208
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: HORIBA Medical sent customer communication letters dated October 24, 2011, to all affected customers via Fax with the exception of two communications that were emailed. The response or confirmation of receipt was conducted via telephone and also documented on attached Notification List. Customers were given a list of procedures to follow and asked to complete and fax the Acknowledgement of Receipt Form to +33 (0)4 67 14 15 17. For questions regarding this recall call 949-453-0500, ext 208.
• Quantity in Commerce: 8,503 units
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CGX