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U.S. Department of Health and Human Services

Class 2 Device Recall ABX PENTRA 400 I.S.E. Module

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  Class 2 Device Recall ABX PENTRA 400 I.S.E. Module see related information
Date Initiated by Firm March 20, 2013
Date Posted April 18, 2013
Recall Status1 Terminated 3 on September 26, 2014
Recall Number Z-1141-2013
Recall Event ID 64723
510(K)Number K052007  
Product Classification Electrode, ion specific, sodium - Product Code JGS
Product HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below.

Used to measure absorbance and ion electrodes.
Code Information Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
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 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above the validated linearity range for each assay.
FDA Determined
Cause 2		 Software design
Action A recall letter, Field Safety Notice & Acknowledgement mailed to the customers March 20, 2013. The letter included the product information, reason for recall, instructions on what to do with the recalled product, and contact information:"If you have any questions or concerns, please contact your local HORIBA Medical representative. We sincerely apologize for any inconvenience this may cause your laboratory. Please contact your Customer Service Representative at 1-888-903-5001 (option 3) for any additional questions related to this customer letter."
Quantity in Commerce 905 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 = JGS and Original Applicant = HORIBA ABX
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