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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Product Detail

Product Description 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 uring.
Recall Number Z-0633-2013
Classification Class II
Code Info Lot number: 00456-4108
Product Distributed Qty 384 units
Reason For Recall 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.

Event Detail

Event Id 63838
Product Type Devices
Status Ongoing
Recalling Firm Horiba Instruments, Inc dba Horiba Medical
City Irvine
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.