Z-1173-2014Class II

Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions...

Name: Z-1173-2014 Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions...
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2014-02-14
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2014-02-14 / Terminated / root cause: software

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The... on 2014-02-14. FDA classified it as Class II and gives the reason as "HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1173-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-14
Posted: 2014-03-11
Terminated: 2014-08-22
Recalling firm: Horiba Instruments Incorporated
Product: Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System.
Root cause tag: software
FDA root cause: Software design
Action: Horiba sent an "URGENT SAFETY NOTICE letter datedFebruary 13, 2014 via by mail to customers. The letter identified the affected product, issue, impact, actions to be taken. Customers were instructed to share this information with laboratory staff and retain this notification as part of their laboratory documentation. Customers were requested to complete and return the enclosed response form via one of the following methods: Fax: 949-453-0600 Email: [email protected] Mail: HORIBA Medical Attention: Jim Knowles, Recall Coordinator 34 Bunsen Drive Irvine, CA 92618. For questions contact your local Horiba Medical representative.
Quantity in commerce: 15
Distribution: USA Nationwide Distribution
Product codes and lots: Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1173-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1173-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-10

Product code JQP

K053308Class IIAbx Micros Crp 200, Option ImHoriba Abx / cleared 2005-12-29

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)