Z-0924-2014Class III

ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control...

Name: Z-0924-2014 ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control...
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2013-12-18
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2013-12-18 / Terminated

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human... on 2013-12-18. FDA classified it as Class III and gives the reason as "HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0924-2014
Classification: Class III
Status: Terminated
Initiated: 2013-12-18
Posted: 2014-02-03
Terminated: 2014-10-09
Recalling firm: Horiba Instruments Incorporated
Product: ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine assay on ABX PENTRA Chemistry Analyzers that the Target Range for Creatinine has been updated. The ABX PENTRA Urine Control L/H lot specific annexes have been updated to include revised acceptable Target Ranges for Creatinine.No other analyte values are affected.
FDA root cause: Pending
Action: HORIBA Medical sent an Urgent Safety Notice dated December 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to update their Quality Control procedures to include the new Creatinine Target Ranges for the ABX PENTRA Urine Control L/H Reference #: A11A01674 and Lot #s: 1207001, 1303601, and 1300701. Customers were instructed to complete and return the enclosed response form to verify their understanding of the Field Safety Notice. Customers with questions were instructed to contact their local HORIBA Medical representative. For questions regarding this recall call 949-453-0500.
Quantity in commerce: 531
Distribution: Worldwide Distribution - USA (nationwide) and Canada.
Product codes and lots: Model/Part #(s): A11A01674. Lot/Serial #(s): 1207001, 1303601, and 1300701. Shelf Life: Lot#s 1207001 & 1300701 Expire on: 06/30/2014. Lot# 1303601 Expires on: 09/30/2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0924-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0924-2014	Class III	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

Product code JJY

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)