Z-0904-2014Class II

ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by...

Name: Z-0904-2014 ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by...
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2013-11-21
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2013-11-21 / Terminated

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative... on 2013-11-21. FDA classified it as Class II and gives the reason as "Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0904-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-21
Posted: 2014-01-31
Terminated: 2014-10-28
Recalling firm: Horiba Instruments Incorporated
Product: ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
Reason for recall: Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
FDA root cause: Under Investigation by firm
Action: Horiba sent an customer notification letter dated November 32, 2013, to all affected customers. The letter was sent via email to all customers who purchased the ABX PENTRA 400. HORIBA Medical is informing all ABX PENTRA N Control customers running the Potassium-E assay on the ABX PENTRA 400 with I.S.E. Module that the Target Value and Target Range for Potassium has been updated. The letter informs the customers of the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days by fax (949) 453-0600 Customers with questions are instructed to contact their local HORIBA Medical representative. For further questions please call (949) 453-0500 X 208
Quantity in commerce: 698 units total (80 units in US)
Distribution: Worldwide Distribution - USA (nationwide)
Product codes and lots: Lot No. 1300801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0904-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0904-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-01-31

Product code JJY

K052007Class IIAbx Pentra 400 Clinical Chemistry Analyzer (Option: I.s.e. Module)Horiba Abx / cleared 2005-12-16

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)