FDAFDA · Food and drugs·Recall number Z-0632-2013
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.
Published January 9, 2013 · Recall initiated: October 10, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Distributor
- Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.
- Lot
- Lot number: 00456-4108
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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