||March 05, 2014
|Recall Event ID
Calibrator, Multi-Analyte Mixture - Product Code JIX
||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.
||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.
|Horiba Instruments, Inc dba Horiba Medical
Irvine, California 92618-4210
|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
|OTHER/UNDETERMINED: Under Investigation by the firm
||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
||United States. No International.
|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)s with Product Code = JIX and Original Applicant = HORIBA ABX S.A.S.