Company: Horiba Instruments, Inc dba Horiba Medical
Date of Enforcement Report 1/9/2013
Class ll:
PRODUCT
ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry. Recall Number Z-0632-2013
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
66886 units
DISTRIBUTION
Nationwide
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