Z-1146-2014Class II

ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop...

Name: Z-1146-2014 ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop...
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2014-01-20
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2014-01-20 / Terminated

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of 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... on 2014-01-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1146-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-20
Posted: 2014-03-05
Terminated: 2014-12-05
Recalling firm: Horiba Instruments Incorporated
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.
Product code: JIX Calibrator, Multi-Analyte Mixture
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 root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1146-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1146-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-05

Product code JIX

K110530Class IIAbx Pentra Creatinine 120 Cp; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine ControlHoriba Abx Sas / cleared 2012-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)