Z-0645-2013Class II

ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

Name: Z-0645-2013 ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2012-09-20
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2012-09-20 / Terminated / root cause: software

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 on 2012-09-20. FDA classified it as Class II and gives the reason as "Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information...". 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-0645-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-20
Posted: 2013-01-07
Terminated: 2013-03-12
Recalling firm: Horiba Instruments Incorporated
Product: ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software
Root cause tag: software
FDA root cause: Software design
Action: .A recall letter dated 11/09/2012 was sent to all their customers who received the ABX PENTRA ML products. The letter informed the customers of the problem identified and the action to be taken. Customers are instructed to complete and return the enclose response form within 10 days. Customers with questions about the letter are instructed to contact their local HORIBA Medical representative. Recall Letter, as produced per FCD-0377, Field Safety Notice & Acknowledgement will be mailed via FedEx to the ten (10) customers noted on the list the week of November 12, 2012. Effectivity will be evaluated by receipt of the Field Safety Notice Acknowledgment Form. Follow-up communications with customers will be conducted, as needed.
Quantity in commerce: 10 units
Distribution: Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.
Product codes and lots: Lot/Serial# PML0937

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0645-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0645-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-07

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)