Z-0289-2013Class III

ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707...

Name: Z-0289-2013 ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707...
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2012-09-14
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2012-09-14 / Terminated / root cause: manufacturing process

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120... on 2012-09-14. FDA classified it as Class III and gives the reason as "This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using the Creatinine...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0289-2013
Classification: Class III
Status: Terminated
Initiated: 2012-09-14
Posted: 2012-11-14
Terminated: 2012-11-29
Recalling firm: Horiba Instruments Incorporated
Product: ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.
Product code: CGX Alkaline Picrate, Colorimetry, Creatinine
Reason for recall: This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: HORIBA Medical sent customer communication letters dated October 24, 2011, to all affected customers via Fax with the exception of two communications that were emailed. The response or confirmation of receipt was conducted via telephone and also documented on attached Notification List. Customers were given a list of procedures to follow and asked to complete and fax the Acknowledgement of Receipt Form to +33 (0)4 67 14 15 17. For questions regarding this recall call 949-453-0500, ext 208.
Quantity in commerce: 8,503 units
Distribution: Nationwide Distribution
Product codes and lots: Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0289-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0289-2013	Class III	Terminated	Voluntary: Firm initiated	2012-11-21	2012-11-14

Product code CGX

K072115Class IIAbx Pentra Creatinine 120 Cp, Total Protein 100 Cp, Multical, N and P Controls, and Urine Control L/hHoriba Abx / cleared 2007-11-30

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)