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Horiba Instruments, Inc dba Horiba Medical recalls ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in
Recalled January 9, 2013 · FDA recall Z-0632-2013 · Horiba Instruments, Inc
Hazard
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. · FDA Class II
Units
66886 units
Sold at
Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
Description
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.
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.
Manufacturer(s)
Horiba Instruments, Inc dba Horiba Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →