FDA Medical Device Recalls (openFDA)
Horiba Instruments, Inc dba Horiba Medical: 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.
- Recall number
- Z-1050-2013
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- 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.
- Status
- Terminated
- Initiated
- 2013-02-15
- Posted
- 2013-04-03
- Terminated
- 2014-08-11
- Reason
- Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
- 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
- 180 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3002698356
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28