Company: Horiba Instruments, Inc dba Horiba Medical
Date of Enforcement Report 1/16/2013
Class ll:
PRODUCT
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Recall Number Z-0645-2013
REASON
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 versions are Versions 9.0.1, 9.0.2, 8.0x and below.
RECALLING FIRM/MANUFACTURER
Horiba Instruments, Inc dba Horiba Medical, Irvine, CA 9/20/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide
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