Horiba Instruments, Inc dba Horiba Medical: Medical Device Recall in 2013 - (Recall #: Z-0632-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 10, 2012

Date Posted: January 9, 2013

Recall Number: Z-0632-2013

Event ID: 63838

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.

Status: Terminated

Product Quantity: 66886 units

Code Information:

Lot number: 00456-4108

Distribution Pattern:

Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated