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U.S. Department of Health and Human Services

Class 2 Device Recall ABX PENTRA Multical. ABX PENTRA N Control ABX PENTRA P Control

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  Class 2 Device Recall ABX PENTRA Multical. ABX PENTRA N Control ABX PENTRA P Control see related information
Date Initiated by Firm January 20, 2014
Date Posted March 05, 2014
Recall Status1 Terminated 3 on December 05, 2014
Recall Number Z-1146-2014
Recall Event ID 67332
510(K)Number K110530  
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
Product ABX PENTRA Multical.
ABX PENTRA N Control.
ABX PENTRA P Control.

The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two
measuring principals: absorbance and ion selective electrodes.
The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical
additives and materials of biological origin. The assigned values of the calibrator
components are given in the enclosed annex, ensuring optimal calibration of the
appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry
Analyzer. This calibrator is provided in ten vials of 3 ml.
Code Information Model Numbers:Multical - A11A01652, N Control - A11A01653, P Control - A11A01654.  Lot Numbers: MultiCal: 1204101 and 1304901, N Control: 1300801, P Control: 1300601.  Expiration Date (s): MultiCal: 1204101 Expires on 05/31/14, MultiCal: 1304901 Expires on 07/15/15, N Control: 1300801 Expires on 11/05/14, P Control: 1300601 Expires on 11/05/14.
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 MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine Rate Blank Method have been updated. This issue is only applicable to Creatinine Rate Blank Method values reported on the ABX PENTRA 400 and PC200 Chemistry Analyzers only. No other analyzers
FDA Determined
Cause 2		 Under Investigation by firm
Action HORIBA Medical initiated this recall by sending customers recall communication via FedEx week of January 20, 2014. The recall communication was a Field Safety Notice letter and Acknowledgement Form. The letter, dated 01/20/2014, titled "URGENT SAFETY NOTICE", informed customers of the recall by providing product description and codes, issue, impact, actiona/resolution, and contact information. The letter contained the following attachments: Field Safety Notice Acknowledgement Form and Updated Annexes with re-assigned values.
Quantity in Commerce 2,023 units
Distribution United States 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 = JIX and Original Applicant = HORIBA ABX S.A.S.
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