FDA-Device2013-01-09Class II
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.
Horiba Instruments, Inc dba Horiba Medical
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.
Sold states
Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
Affected count
66886 units
Manufactured in
34 Bunsen, N/A, Irvine, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0632-2013Don't want to check this manually?
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