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U.S. Department of Health and Human Services

Class 3 Device Recall ABX PENTRA Creatinine 120 CP

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 Class 3 Recall
ABX PENTRA Creatinine 120 CP
see related information
Date Posted November 14, 2012
Recall Status1 Terminated on November 29, 2012
Recall Number Z-0289-2013
Recall Event ID 63536
Premarket Notification
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, California 92618-4210
Consumer Instructions Contact the recalling firm for information
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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CGX and Original Applicant = HORIBA ABX
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