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Terminated

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.

FDA Recall Z-1050-2013 · Posted 2013-04-03

Recalling FirmHoriba Instruments, Inc dba Horiba Medical
Recall StatusTerminated
Product CodeJQP
Date Initiated2013-02-15
Date Terminated2014-08-11
Product Quantity180 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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