Company: Horiba Instruments Inc
Date of Enforcement Report 5/4/2016
Class lI:
PRODUCT
Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes. Recall Number Z-1554-2016
REASON
Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.
RECALLING FIRM/MANUFACTURER
Horiba Instruments Inc., Irvine, CA on 2/19/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
201
DISTRIBUTION
Nationwide
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