ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Softwa
FDA device recall Z-1050-2013 · posted 2013-04-03 · Terminated
Recall details
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 180 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-02-15
- Date posted
- 2013-04-03
- Date terminated
- 2014-08-11
- Location
- Irvine, CA
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