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 | K110137 K110530 |
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.
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510(K) Database | 510(K)s with Product Code = JJY
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