Z-1050-2013Class III

ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data...

Name: Z-1050-2013 ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data...
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2013-02-15
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2013-02-15 / Terminated / root cause: design

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse... on 2013-02-15. FDA classified it as Class III and gives the reason as "Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1050-2013
Classification: Class III
Status: Terminated
Initiated: 2013-02-15
Posted: 2013-04-03
Terminated: 2014-08-11
Recalling firm: Horiba Instruments Incorporated
Product: ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
Root cause tag: design
FDA root cause: Device Design
Action: Horiba Medical sent an Urgent Safety Notice dated February 15, 2013, to all affected customers. The letter informed the customers that Horiba Medical is informing all ABX Micros IM2 Data Management System customers of their intention to remove the ABX Micros IM2 product from the market. The letter informed the customers of the problem identified and the action to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. For questions regarding this recall call 949-453-0500, ext 208.
Quantity in commerce: 180 units
Distribution: Nationwide Distribution
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1050-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1050-2013	Class III	Terminated	Voluntary: Firm initiated	2013-04-10	2013-04-03

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)