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U.S. Department of Health and Human Services

Class 3 Device Recall ABX PENTRA Urine Control L/H

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  Class 3 Device Recall ABX PENTRA Urine Control L/H see related information
Date Initiated by Firm December 18, 2013
Date Posted February 03, 2014
Recall Status1 Terminated 3 on October 09, 2014
Recall Number Z-0924-2014
Recall Event ID 67133
510(K)Number K110530  K110137  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product ABX PENTRA Urine Control L/H.

The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control
consisting of liquid solutions prepared from human urine with chemical additives and
materials of biological origin added as required to obtain given component levels. The
assigned values of the control components are given in the labeling, ensuring control of
the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers.
Each control level is provided in one vial of 10 ml.

The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
Code Information Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701. Shelf Life: Lot#s 1207001 & 1300701 Expire on: 06/30/2014. Lot# 1303601 Expires on: 09/30/2014. 
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		 HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific annexes have been updated to include revised acceptable Target Ranges for Creatinine.No other analyte values are affected.
FDA Determined
Cause 2		 Pending
Action HORIBA Medical sent an Urgent Safety Notice dated December 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to update their Quality Control procedures to include the new Creatinine Target Ranges for the ABX PENTRA Urine Control L/H Reference #: A11A01674 and Lot #s: 1207001, 1303601, and 1300701. Customers were instructed to complete and return the enclosed response form to verify their understanding of the Field Safety Notice. Customers with questions were instructed to contact their local HORIBA Medical representative. For questions regarding this recall call 949-453-0500.
Quantity in Commerce 531
Distribution Worldwide Distribution - USA (nationwide) and Canada.
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 = JJY and Original Applicant = HORIBA ABX S.A.S.
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