Company: Horiba Instruments, Inc dba Horiba Medical
Date of Enforcement Report 1/9/2013
Class ll:

PRODUCT

PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and urine. Recall Number Z-0633-2013

REASON
Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) were recorded at 280 and 199 U/L without alarm.

RECALLING FIRM/MANUFACTURER
Horiba Instruments, Inc dba Horiba Medical, Irvine, CA 10/10/2012. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
384 units

DISTRIBUTION
Nationwide

___________________________________